Dx Pipeline Status

DX Pipeline

Showing to of columns
Disease
  • Show All
  • Tuberculosis
  • Malaria
  • Fever
  • HAT
  • Chagas
  • Buruli ulcer
  • Leishmaniasis
TPP - Select Disease first
  • Show All
  • A rapid biomarker-based non-sputum-based test for detecting TB
  • Community-based triage or referral test for identifying people suspected of having TB
  • Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
  • Next-generation drug-susceptibility testing at microscopy centres
  • Centralized drug susceptibility testing (DST)
  • Test for incipient TB
  • Treatment monitoring or test of cure
  • Sample transport solution
  • Other
  • Pf: P. falciparum (subpatent)
  • PvA: P. vivax (acute)
  • PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • PvB1/PvB2: P. vivax (subpatent)
  • Other
  • Bacterial versus non-bacterial differentiation test for fever
  • Other
  • Screening
  • Screening/Diagnosis
  • Congenital (acute) Chagas disease
  • Test of cure
  • Diagnosis
  • Diagnosis
  • Test of cure
FIND Portfolio
  • Show All
  • Yes
  • No
  • In discussion
Health Level
  • Show All
  • L0-Community
  • L1-Microscopy Center
  • L2-District Lab/Hospital
  • L3-Reference Laboratory
  • NA
Company Size
  • Show All
  • Pre-Company
  • Micro
  • Small
  • Medium
  • Large
  • Research Institute
  • Other
  • NA
Tuberculosis
Malaria
Fever
HAT
Chagas
Buruli ulcer
Leishmaniasis
1 Feasibility
Pre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org
2 Development
Pre-requisite: Dev. under QMS / Analytical data available
Obj: Assay optimization / Manufacturability assessment
Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
URL: www.tbdxpathway.org
3 Validation
Pre-requisite: Design locked product or near / Pilot line for manufacturing
Obj: Laboratory/clinical validation
Milestone: Statistically powered studies on patient samples / Manufacturing in place
URL: www.tbdxpathway.org
4 Regulatory
Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org
5 WHO evaluation
Obj: Evaluation or demonstration studies to inform WHO policy
Milestone: WHO endorsement / Pre-qualified products
URL: www.tbdxpathway.org
6 Country transition
Pre-requisite: Global Policy Report available
Obj: In-country feasibility / Dev. of specific training materials
Milestone: Getting on Global Fund list / Supply chain for initial demand
URL: www.tbdxpathway.org
7 Country adoption
Milestone: Diagnostic algorithm or Country policy change
URL: www.tbdxpathway.org
8 Scale-up & Impact
Pre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org

Incipient TB Assay

Abbott Laboratorie...

RiView-TB

Advenio TecnoSys

BreathTest

Avisa Pharma Inc.

T-cell Immune Prof...

Becton-Dickinson

Genedrive MTB

Genedrive PLC

Low-cost Easy to U...

Multiple

InSilixa HYDRA-1k

InSilixa, Inc.

TBDx System projec...

Keck Graduate Inst...

NANO4Pathogen

Nano4Global

BioNanoPore

NanoLogix, Inc.

NS-POC TB Detector

NanoSynth

QFT-Predict

Qiagen

QIA-TB Signature

Qiagen

TB Breathalyser

Rapid Biosensor Sy...

TB Flow

Salus Discovery, L...

Scanogen

Scanogen, Inc.

NA-NOSE

Breathtec Biomedic...

MtB Drug Resistanc...

Omniome, Inc.

Blood host marker ...

Multiple

MTB-antigens POC a...

Multiple

Blood/urine cfDNA ...

Multiple

High sensitivity T...

Global Good

TruArray MDR-TB

Akonni Biosystems ...

TruArray XDR-TB

Akonni Biosystems ...

PoC

Bioneer

Xpert XDR

Cepheid

Omni

Cepheid

FluoroType MTBXDR ...

Hain Lifescience G...

RTT TB

Lophius Bioscience...

LabChip-based Rapi...

MicoBiomed

UltraFast LabChip ...

MicoBiomed

Q-POC TB/MDR TB

QuantuMDx

TB MultiTest

SelfDiagnostics De...

Molecular Stool

Multiple

INFINITI MDR-TB

AutoGenomics

AccuPower XDR-TB R...

Bioneer

INNO-LiPA Rif.TB

Fuji-Rebio Europe

Sensitive LAM

Fujifilm

ID-FISH assay

ID-FISH Technology...

AdvanSure MDR-TB G...

LG Life Sciences

PrimeSuite TB

Longhorn Vaccines ...

QMAC DST

QuantaMatrix, Inc.

Aeonose for TB

The eNose Company

VereMTB Detection ...

Veredus Laboratori...

TB Resistance Modu...

Autoimmun Diagnost...

AccuPower TB&MDR R...

Bioneer

Tuberculosis Drug ...

CapitalBio Technol...

OMNIgene SPUTUM

DNA Genotek, Inc.

FluoroType MTB VER...

Hain Lifescience G...

PrimeStore MTM

Longhorn Vaccines ...

Truenat MTB

Molbio Diagnostics

Truenat MTB RIF Dx

Molbio Diagnostics

LAM-ELISA

Otsuka Pharmaceuti...

MTB drug-resistant...

QuanDx

Mycolor TK platfor...

Salubris

Anyplex assays for...

Seegene, Inc.

VersaTREK

Thermo Fisher

Sensititre MYCOTB ...

Thermo Fisher

MolecuTech REBA MD...

YD Diagnostics

MeltPro MTB (MDR-T...

Zeesan Biotech

RealTime MTB RIF/I...

Abbott Laboratorie...

BD MAX MDR-TB

Becton-Dickinson

MGIT-Bedaquiline&D...

Becton-Dickinson

Qure Chest X-rays ...

Qure.ai

CAD4TB

Delft Imaging Syst...

FluoroType MTBDR V...

Hain Lifescience G...

Cobas MTB-RIF/INH

Roche

Determine TB LAM A...

Alere Inc.

Xpert MTB/RIF Ultr...

Cepheid

Loopamp MTBC assay

Eiken Chemical Co....

BACTEC MGIT System

Becton-Dickinson

BacT/ALERT 3D

Biomérieux

Xpert MTB/RIF

Cepheid

GenoType MTBDRsl V...

Hain Lifescience G...

GenoType MTBDRsl V...

Hain Lifescience G...

GenoType MTBDRplus...

Hain Lifescience G...

GenoType MTBDRplus...

Hain Lifescience G...

NTM+MDRTB

Nipro

LED Microscopy

Multiple

Mycobacterial cult...

Multiple

Hemozoin detection...

Budapest Universit...

NA

Indian Institute o...

Attenuated total r...

Monash University,...

Sero-surveillance ...

Walter and Eliza H...

Sero-test and trea...

Walter and Eliza H...

Serology assay for...

IS Global

Battery/solar powe...

One world Cytometr...

Pinpoint Malaria M...

Pinpoint Science I...

ASPIRE

VisionQuest Biomed...

HS RDT

AccessBio

Parasight POC

Sight Diagnostics ...

Q-POC system with ...

QuantuMDx

Accutas

Aquila Diagnostics...

Rapid Assessment o...

Disease Diagnostic...

Transdermal detect...

Rice University, M...

xRapid-Malaria

xRapid

Serology RDT

Consortium

Serology RDT

Burnet Institute; ...

Truelab micro PCR ...

Molbio Diagnostics

NALFIA DIAGMAL

DIAGMAL Consortium

Magneto-optical De...

Meditopian LLC and...

Autoscope

Global Good Fund a...

miLab Malaria

noul Inc.

ID-FISH Plasmodium...

ID-FISH Technology...

Alere Malaria Ag P...

Alere/Standard Dia...

Urine Malaria Test

Fyodor Biotechnolo...

Parasight

Sight Diagnostics ...

Loopamp MALARIA Pa...

Eiken Chemical Co....

High throughput LA...

Eiken Chemical Co....

Illumigene Malaria

Meridian Bioscienc...

Malaria serology E...

Multiple

Malaria serology R...

Multiple

Malaria RDT

Multiple

HostDx Fever

Inflammatix, Inc.

ImmunoPOC

Memed Diagnostics

Malaria/CRP duo te...

SD Biosensor

BD Veritor POC Fev...

Becton&Dickinson

FebriDx

RPS Diagnostics

Landscape CRP Test...

Multiple

Landscape PCT Test...

Multiple

iELISA (immune try...

Institute of Tropi...

SD BIOLINE HAT/Mal...

Standard Diagnosti...

2nd generation RDT...

Coris BioConcept

SD BIOLINE HAT

Standard Diagnosti...

HAT Sero K-SeT

Coris BioConcept

SD BIOLINE HAT 2.0

Standard Diagnosti...

Loopamp Trypanosom...

Eiken Chemical Co....

InfYnity Chagas To...

InfYnity Biomarker...

NA

Multiple

CHUNAP (not define...

Multiple

SAPA (not defined)

Multiple

Loopamp Trypanosom...

Eiken Chemical Co....

LAMP Chagas (not d...

Multiple

BU ELONA (not defi...

Aptagen LLC

BUD-LAMP (not defi...

DITM/KUM, NMIMR, O...

BU-RDT (not define...

Standard Diagnosti...

f-TLC

Harvard University

Leishmaniasis-RDT ...

Multiple

LD RPA (not define...

TwistDx

RPA-LF (not define...

TwistDx

Leismaniasis IgG1-...

Coris BioConCept

Loopamp Leishmania...

Eiken Chemical Co....

VL ELISA

Kalon Biological L...

Leishmania Antigen...

InBios Internation...

CL Detect Rapid Te...

InBios Internation...

Leishmania OligoC-...

Coris BioConcept

SD BIOLINE Leishma...

Standard Diagnosti...

IT-Leish

BIO-RAD

Kalazar Detect

InBios Internation...

Leishmania IgG/IgM...

CTK Biotech

Leishmania Ab Rapi...

CTK Biotech

Leishmania Ab ELIS...

CTK Biotech

Katex

Kalon Biological L...

STAT-NAT Leishmani...

Sentinel Diagnosti...

RealTime MTB RIF/INH

Tuberculosis

Update Date: 25.06.18
  • Company Name: Abbott Laboratories
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 5-WHO evaluation
    Obj: Evaluation or demonstration studies to inform WHO policy
    Milestone: WHO endorsement / Pre-qualified products
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: This assay runs on m2000sp and m2000rt from Abbott.

Incipient TB Assay

Tuberculosis

Update Date: 02.10.17
  • Company Name: Abbott Laboratories
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: NA
  • Biomarker Type: NA
  • TPP: Test for incipient TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: This assay runs on m2000sp and m2000rt from Abbott.

RiView-TB

Tuberculosis

Update Date: 20.06.17
  • Company Name: Advenio TecnoSys
  • Company Size: NA
  • Product Type: Adjunct tool
  • Technology Type: Imaging
  • Biomarker Type: Other
  • TPP: Community-based triage or referral test for identifying people suspected of having TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark:

TruArray MDR-TB

Tuberculosis

Update Date: 28.11.17
TruArray MDR-TB
  • Company Name: Akonni Biosystems Inc.
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: This assay runs on TruDx3000 from Akonni.

TruArray XDR-TB

Tuberculosis

Update Date: 28.11.17
TruArray XDR-TB
  • Company Name: Akonni Biosystems Inc.
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: This assay runs on TruDx3000 from Akonni.

Determine TB LAM Ag

Tuberculosis

Update Date: 20.06.17
  • Company Name: Alere Inc.
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: A rapid biomarker-based non-sputum-based test for detecting TB
  • Pathway Status: 6-Country pre-launch
    Pre-requisite: Global Policy Report available
    Obj: In-country feasibility / Dev. of specific training materials
    Milestone: Getting on Global Fund list / Supply chain for initial demand
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

INFINITI MDR-TB

Tuberculosis

Update Date: 20.06.17
  • Company Name: AutoGenomics
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: RUO Product.

TB Resistance Module series

Tuberculosis

Update Date: 20.06.17
  • Company Name: Autoimmun Diagnostika (AID)
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

BreathTest

Tuberculosis

Update Date: 20.06.17
  • Company Name: Avisa Pharma Inc.
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Dx Assay
  • Technology Type: Spectroscopy
  • Biomarker Type: Metabolite
  • TPP: Community-based triage or referral test for identifying people suspected of having TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark:

BD MAX MDR-TB

Tuberculosis

Update Date: 06.08.18
  • Company Name: Becton-Dickinson
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 5-WHO evaluation
    Obj: Evaluation or demonstration studies to inform WHO policy
    Milestone: WHO endorsement / Pre-qualified products
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: The assay runs on the BD MAX System which is a fully-integrated, automated platform that performs nucleic acid extraction and real-time PCR.

BACTEC MGIT System

Tuberculosis

Update Date: 20.06.17
  • Company Name: Becton-Dickinson
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Platform
  • Technology Type: Growth based
  • Biomarker Type: Whole bug
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

MGIT-Bedaquiline&Delamanid

Tuberculosis

Update Date: 25.06.18
  • Company Name: Becton-Dickinson
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: Growth based
  • Biomarker Type: Whole bug
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 5-WHO evaluation
    Obj: Evaluation or demonstration studies to inform WHO policy
    Milestone: WHO endorsement / Pre-qualified products
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

T-cell Immune Profiling

Tuberculosis

Update Date: 02.10.17
  • Company Name: Becton-Dickinson
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: NA
  • Biomarker Type: NA
  • TPP: Test for incipient TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

BacT/ALERT 3D

Tuberculosis

Update Date: 20.06.17
  • Company Name: Biomérieux
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Platform
  • Technology Type: Growth based
  • Biomarker Type: Whole bug
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

AccuPower TB&MDR Real-Time PCR

Tuberculosis

Update Date: 27.11.17
AccuPower TB&MDR Real-Time PCR
  • Company Name: Bioneer
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: This PCR product is closed system on ExiStation Molecular Diagnostics System of BIONEER

PoC

Tuberculosis

Update Date: 27.11.17
  • Company Name: Bioneer
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Platform
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

AccuPower XDR-TB Real-Time PCR

Tuberculosis

Update Date: 27.11.17
  • Company Name: Bioneer
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: This product is closed system on ExiStation Molecular Diagnostics System of Bioneer

Tuberculosis Drug Resistance Detection Array Kit

Tuberculosis

Update Date: 20.06.17
  • Company Name: CapitalBio Technology
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Xpert XDR

Tuberculosis

Update Date: 20.06.17
  • Company Name: Cepheid
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

Omni

Tuberculosis

Update Date: 06.04.17
  • Company Name: Cepheid
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Platform
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

Xpert MTB/RIF Ultra

Tuberculosis

Update Date: 20.06.17
  • Company Name: Cepheid
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 6-Country pre-launch
    Pre-requisite: Global Policy Report available
    Obj: In-country feasibility / Dev. of specific training materials
    Milestone: Getting on Global Fund list / Supply chain for initial demand
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

Xpert MTB/RIF

Tuberculosis

Update Date: 20.06.17
  • Company Name: Cepheid
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

Qure Chest X-rays for TB

Tuberculosis

Update Date: 19.04.18
  • Company Name: Qure.ai
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Adjunct Tool
  • Technology Type: Imaging
  • Biomarker Type: Other
  • TPP: Community-based triage or referral test for identifying people suspected of having TB
  • Pathway Status: 5-WHO evaluation
    Obj: Evaluation or demonstration studies to inform WHO policy
    Milestone: WHO endorsement / Pre-qualified products
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: a fully automated robust deep learning algorithm that detects abnormal findings on chest X–ray and combines these findings to detect abnormalities suggestive of pulmonary tuberculosis

CAD4TB

Tuberculosis

Update Date: 19.04.18
  • Company Name: Delft Imaging Systems
  • Company Size: NA
  • Product Type: Adjunct Tool
  • Technology Type: Imaging
  • Biomarker Type: Other
  • TPP: Community-based triage or referral test for identifying people suspected of having TB
  • Pathway Status: 5-WHO evaluation
    Obj: Evaluation or demonstration studies to inform WHO policy
    Milestone: WHO endorsement / Pre-qualified products
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: Yes
  • Remark: Software has been certified in 2015 (CE-mark)

OMNIgene SPUTUM

Tuberculosis

Update Date: 19.04.18
  • Company Name: DNA Genotek, Inc.
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Adjunct Tool
  • Technology Type: NA
  • Biomarker Type: NA
  • TPP: Sample transport solution
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: OMNIgene SPUTUM is a non-toxic and highly stable reagent that liquefies and decontaminates sputum samples at the point-of-collection or in the lab while preserving MTB viability for at least 8 days at ambient temperatures.

Loopamp MTBC assay

Tuberculosis

Update Date: 20.06.17
  • Company Name: Eiken Chemical Co., Ltd
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
  • Pathway Status: 6-Country pre-launch
    Pre-requisite: Global Policy Report available
    Obj: In-country feasibility / Dev. of specific training materials
    Milestone: Getting on Global Fund list / Supply chain for initial demand
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

INNO-LiPA Rif.TB

Tuberculosis

Update Date: 26.07.17
  • Company Name: Fuji-Rebio Europe
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Sensitive LAM

Tuberculosis

Update Date: 19.04.18
Sensitive LAM
  • Company Name: Fujifilm
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: A rapid biomarker-based non-sputum-based test for detecting TB
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders: GHIT
  • FIND Portfolio: Yes
  • Remark:

Genedrive MTB

Tuberculosis

Update Date: 03.11.17
Genedrive MTB
  • Company Name: Genedrive PLC
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

FluoroType MTBXDR VER 1.0

Tuberculosis

Update Date: 29.09.17
  • Company Name: Hain Lifescience GmbH
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

FluoroType MTBDR VER 1.0

Tuberculosis

Update Date: 25.06.18
  • Company Name: Hain Lifescience GmbH
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 5-WHO evaluation
    Obj: Evaluation or demonstration studies to inform WHO policy
    Milestone: WHO endorsement / Pre-qualified products
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: The amplification and detection are performed in the FluoroCycler 96.

FluoroType MTB VER 1.0

Tuberculosis

Update Date: 20.06.17
  • Company Name: Hain Lifescience GmbH
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Other - Centralized Molecular no DST
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

GenoType MTBDRsl VER 2.0

Tuberculosis

Update Date: 20.06.17
  • Company Name: Hain Lifescience GmbH
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

GenoType MTBDRsl VER 1.0

Tuberculosis

Update Date: 20.06.17
  • Company Name: Hain Lifescience GmbH
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

GenoType MTBDRplus VER 2.0

Tuberculosis

Update Date: 20.06.17
  • Company Name: Hain Lifescience GmbH
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

GenoType MTBDRplus VER 1.0

Tuberculosis

Update Date: 20.06.17
  • Company Name: Hain Lifescience GmbH
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

ID-FISH assay

Tuberculosis

Update Date: 20.06.17
  • Company Name: ID-FISH Technology Inc.
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Adjunct Tool
  • Technology Type: Microscopy
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Low-cost Easy to Use NGS

Tuberculosis

Update Date: 25.06.18
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Sequencing
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: Illumina, Genoscreen, Tgen, BMS, Longhorn, ...

InSilixa HYDRA-1k

Tuberculosis

Update Date: 08.01.18
InSilixa HYDRA-1k
  • Company Name: InSilixa, Inc.
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Platform
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: This is a high-multiplex NAAT CMOS biochip platform technology that will support TB-XDR diagnosis in addition to other infectious diseases.

TBDx System project

Tuberculosis

Update Date: 20.06.17
  • Company Name: Keck Graduate Institute (KGI)
  • Company Size: Not A Commercial Entity
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark:

AdvanSure MDR-TB GenoBlot Assay

Tuberculosis

Update Date: 20.06.17
  • Company Name: LG Life Sciences
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

PrimeSuite TB

Tuberculosis

Update Date: 20.06.17
PrimeSuite TB
  • Company Name: Longhorn Vaccines and Diagnostics LLC
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: Sequencing
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: PrimeSuite TB is an end-to-end solution for active tuberculosis infection screening and genetic analysis of drug resistance. It works on most open platform Real-time PCR platforms and Next Generation sequencers, and can be integrated with many high throughput extraction systems.

PrimeStore MTM

Tuberculosis

Update Date: 20.06.17
PrimeStore MTM
  • Company Name: Longhorn Vaccines and Diagnostics LLC
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Adjunct tool
  • Technology Type: NA
  • Biomarker Type: NA
  • TPP: Sample transport solution
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: PrimeStore MTM is a solution for collection, transport, and storage of specimens for nucleic acid testing and analysis. It is also a system for short, medium, and long-term storage of samples.

RTT TB

Tuberculosis

Update Date: 20.06.17
  • Company Name: Lophius Biosciences
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: NA
  • Biomarker Type: NA
  • TPP: Test for incipient TB
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Truenat MTB

Tuberculosis

Update Date: 20.06.17
Truenat MTB
  • Company Name: Molbio Diagnostics
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: Chip-based Real Time micro PCR Tests, for automatic amplification and analysis of extracted nucleic acids with Truelab real time micro PCR analyzer & Trueprep sample prep device.

Truenat MTB RIF Dx

Tuberculosis

Update Date: 20.06.17
Truenat MTB RIF Dx
  • Company Name: Molbio Diagnostics
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: Chip-based Real Time micro PCR Tests, for automatic amplification and analysis of extracted nucleic acids with Truelab real time micro PCR analyzer & Trueprep sample prep device.

NANO4Pathogen

Tuberculosis

Update Date: 20.06.17
  • Company Name: Nano4Global
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark:

LabChip-based Rapid POCT

Tuberculosis

Update Date: 18.04.18
  • Company Name: MicoBiomed
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Platform
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: Development of an automated, fully integrated and portable sample-to-answer device.

UltraFast LabChip Real-time PCR - MDR-TB kit

Tuberculosis

Update Date: 18.04.18
UltraFast LabChip Real-time PCR - MDR-TB kit
  • Company Name: MicoBiomed
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: This molecular real-time PCR assay is running on the UltraFast Sample Prep & UltraFast LabChip Real-time PCR instruments.

BioNanoPore

Tuberculosis

Update Date: 20.06.17
BioNanoPore
  • Company Name: NanoLogix, Inc.
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Adjunct Tool
  • Technology Type: Growth based
  • Biomarker Type: Whole bug
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

NS-POC TB Detector

Tuberculosis

Update Date: 20.06.17
  • Company Name: NanoSynth
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Dx Assay
  • Technology Type: Spectroscopy
  • Biomarker Type: Metabolite
  • TPP: Community-based triage or referral test for identifying people suspected of having TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark:

NTM+MDRTB

Tuberculosis

Update Date: 20.06.17
  • Company Name: Nipro
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

LAM-ELISA

Tuberculosis

Update Date: 20.06.17
  • Company Name: Otsuka Pharmaceutical Co., Ltd.
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: Treatment monitoring or test of cure
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

QFT-Predict

Tuberculosis

Update Date: 02.10.17
  • Company Name: Qiagen
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: NA
  • Biomarker Type: NA
  • TPP: Test for incipient TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

QIA-TB Signature

Tuberculosis

Update Date: 02.10.17
  • Company Name: Qiagen
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: NA
  • Biomarker Type: NA
  • TPP: Test for incipient TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

MTB drug-resistant Mutation Test Kits

Tuberculosis

Update Date: 20.06.17
  • Company Name: QuanDx
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

QMAC DST

Tuberculosis

Update Date: 20.06.17
QMAC DST
  • Company Name: QuantaMatrix, Inc.
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: Growth based
  • Biomarker Type: Whole bug
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Q-POC TB/MDR TB

Tuberculosis

Update Date: 17.06.18
  • Company Name: QuantuMDx
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

TB Breathalyser

Tuberculosis

Update Date: 20.06.17
TB Breathalyser
  • Company Name: Rapid Biosensor Systems Ltd
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: Community-based triage or referral test for identifying people suspected of having TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

Cobas MTB-RIF/INH

Tuberculosis

Update Date: 25.06.18
  • Company Name: Roche
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 5-WHO evaluation
    Obj: Evaluation or demonstration studies to inform WHO policy
    Milestone: WHO endorsement / Pre-qualified products
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: For use with the COBAS 6800/8800 Systems

Mycolor TK platform

Tuberculosis

Update Date: 20.06.17
  • Company Name: Salubris
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Platform
  • Technology Type: Growth based
  • Biomarker Type: Whole bug
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

TB Flow

Tuberculosis

Update Date: 12.03.18
  • Company Name: Salus Discovery, LLC
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: A rapid biomarker-based non-sputum-based test for detecting TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark: Urine based LFA test. Test includes a concentration step that aims to improve sensitivity.

Scanogen

Tuberculosis

Update Date: 20.06.17
  • Company Name: Scanogen, Inc.
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: Other
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark:

Anyplex assays for MDR/XDR series

Tuberculosis

Update Date: 20.06.17
  • Company Name: Seegene, Inc.
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

TB MultiTest

Tuberculosis

Update Date: 20.06.17
TB MultiTest
  • Company Name: SelfDiagnostics Deutschland GmbH
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Aeonose for TB

Tuberculosis

Update Date: 20.06.17
Aeonose for TB
  • Company Name: The eNose Company
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Platform
  • Technology Type: Spectroscopy
  • Biomarker Type: Metabolite
  • TPP: Community-based triage or referral test for identifying people suspected of having TB
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

VersaTREK

Tuberculosis

Update Date: 20.06.17
  • Company Name: Thermo Fisher
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: Growth based
  • Biomarker Type: Whole bug
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS:
  • Funders:
  • FIND Portfolio:
  • Remark:

Sensititre MYCOTB MIC plate

Tuberculosis

Update Date: 20.06.17
  • Company Name: Thermo Fisher
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: Growth based
  • Biomarker Type: Whole bug
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: CE-IVD-marked. For research use only in the U.S.

VereMTB Detection Kit

Tuberculosis

Update Date: 01.11.17
VereMTB Detection Kit
  • Company Name: Veredus Laboratories Pte Ltd
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: RUO Product based on multiplex PCR and microarray technology.

MolecuTech REBA MDR/XDR assays series

Tuberculosis

Update Date: 20.06.17
  • Company Name: YD Diagnostics
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

MeltPro MTB (MDR-TB, XDR-TB) kits

Tuberculosis

Update Date: 20.06.17
  • Company Name: Zeesan Biotech
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

LED Microscopy

Tuberculosis

Update Date: 25.06.18
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Platform
  • Technology Type: Microscopy
  • Biomarker Type: Whole bug
  • TPP: Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: E.g. Primo Star iLED (Zeiss)

Molecular Stool

Tuberculosis

Update Date: 05.10.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: NA
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: FIND, ELMA Fdn & Partners, Univ. Bordeaux, Others

NA-NOSE

Tuberculosis

Update Date: 02.10.17
  • Company Name: Breathtec Biomedical, Inc.
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Spectroscopy
  • Biomarker Type: Metabolite
  • TPP: Community-based triage or referral test for identifying people suspected of having TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: In collaboration with the Israel Institute of Technology (‰ÛÏTechnion‰ÛÏ).

MtB Drug Resistance DX

Tuberculosis

Update Date: 21.06.17
  • Company Name: Omniome, Inc.
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: Sequencing
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Next-generation drug-susceptibility testing at microscopy centres
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

Blood host marker POC Tests

Tuberculosis

Update Date: 02.10.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: Community-based triage or referral test for identifying people suspected of having TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: SomaLogic, ScreenTB, Broad Inst., Others

MTB-antigens POC assays

Tuberculosis

Update Date: 30.01.18
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: A rapid biomarker-based non-sputum-based test for detecting TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: NanoTin & ASU, Tufts Univ., Others

Blood/urine cfDNA POC assays

Tuberculosis

Update Date: 02.10.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: A rapid biomarker-based non-sputum-based test for detecting TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: Stanford Univ., Cornell Univ., Karius, Alere/Clondiag, Others

High sensitivity TB rapid diagnostic

Tuberculosis

Update Date: 20.06.17
  • Company Name: Global Good
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: A rapid biomarker-based non-sputum-based test for detecting TB
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark:

Mycobacterial culture & Rapid speciation

Tuberculosis

Update Date: 02.10.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: NA
  • Biomarker Type: NA
  • TPP: Centralized drug susceptibility testing (DST)
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: Tauns, BD, SD-Alere, others

Malaria RDT

Malaria

Update Date: 15.08.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: PvA: P. vivax (acute)
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: See: UNITAID Malaria Diagnostics Technology and Market Landsape 3rd edition, WHO Product Testing and WHO PQ

Alere Malaria Ag P.f

Malaria

Update Date: 15.08.17
  • Company Name: Alere/Standard Diagnostics
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: Pf: P. falciparum (subpatent)
  • Pathway Status: 5-WHO evaluation
    Obj: Evaluation or demonstration studies to inform WHO policy
    Milestone: WHO endorsement / Pre-qualified products
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders: BMGF
  • FIND Portfolio: Yes
  • Remark: Highly sensitive lateral flow immunochromatographic antigen-detection tests

HS RDT

Malaria

Update Date: 15.08.17
  • Company Name: AccessBio
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: Pf: P. falciparum (subpatent)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders: Global Good
  • FIND Portfolio: No
  • Remark: Advanced lateral flow assay and reader system that detects nanoparticles tagged to key biomarkers of malaria.

Urine Malaria Test

Malaria

Update Date: 15.11.15
  • Company Name: Fyodor Biotechnologies
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: PvA: P. vivax (acute)
  • Pathway Status: 6-Country pre-launch
    Pre-requisite: Global Policy Report available
    Obj: In-country feasibility / Dev. of specific training materials
    Milestone: Getting on Global Fund list / Supply chain for initial demand
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders: US SBIR & others
  • FIND Portfolio: No
  • Remark: Lateral flow immunochromatographic antigen-detection test

Parasight

Malaria

Update Date: 15.11.16
  • Company Name: Sight Diagnostics Ltd.
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Platform
  • Technology Type: Microscopy
  • Biomarker Type: Whole bug
  • TPP: PvA: P. vivax (acute)
  • Pathway Status: 6-Country pre-launch
    Pre-requisite: Global Policy Report available
    Obj: In-country feasibility / Dev. of specific training materials
    Milestone: Getting on Global Fund list / Supply chain for initial demand
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: Automated, computer assisted microscopy. Benchtop device using disposable cartridges; quantitative, high throughput (30 samples batched).

Parasight POC

Malaria

Update Date: 15.11.16
  • Company Name: Sight Diagnostics Ltd.
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Platform
  • Technology Type: Microscopy
  • Biomarker Type: Whole bug
  • TPP: PvA: P. vivax (acute)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: Automated, POC computer assisted microscopy. Point of care device using disposable cartridges; quantitative, low throughput (processes one sample at a time)

Truelab micro PCR platform

Malaria

Update Date: 15.11.15
  • Company Name: Molbio Diagnostics
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Platform
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: PvA: P. vivax (acute)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

NALFIA DIAGMAL

Malaria

Update Date: 15.11.15
  • Company Name: DIAGMAL Consortium
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: PCR (LFA)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: PvB1/PvB2: P. vivax (subpatent)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: No
  • Funders: European Framework 7
  • FIND Portfolio: No
  • Remark: PCR: commercial kit uses disposable nucleic acid lateral flow immunoassay (NALFIA) for detection. Kit contains all necessary primers and reagents in stabilized form, as well as NALFIA lateral flow device to run test after amplification on traditional PCR thermocycler.

Q-POC system with malaria assay

Malaria

Update Date: 17.06.18
  • Company Name: QuantuMDx
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Platform
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders: European Framework 7
  • FIND Portfolio: No
  • Remark: POC automated PCR. Hand-held, battery operated POC PCR device. Uses disposable cartridges that are pre-loaded with reagents and probes required to prep sample and run assay. Will include qualitative output for five malaria species; TBD drug resistance testing.

Accutas

Malaria

Update Date: 15.11.15
  • Company Name: Aquila Diagnostics Systems
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Platform
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: POC automated PCR. Hydrogel-based POC PCR, using disposable plastic tubes of desiccated hydrogel reagents for malaria PCR.

Loopamp MALARIA Pan/Pf detection kit

Malaria

Update Date: 15.11.15
  • Company Name: Eiken Chemical Co., Ltd
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • Pathway Status: 6-Country pre-launch
    Pre-requisite: Global Policy Report available
    Obj: In-country feasibility / Dev. of specific training materials
    Milestone: Getting on Global Fund list / Supply chain for initial demand
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: P. vivax test in validation. LAMP: low throughput. Field stable quality assured LAMP kit for simplified, molecular detection using whole blood or dried blood spots. Qualitative results. 8 well format for individual testing.

High throughput LAMP sample processing kit

Malaria

Update Date: 15.11.15
  • Company Name: Eiken Chemical Co., Ltd
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: PvB1/PvB2: P. vivax (subpatent)
  • Pathway Status: 6-Country pre-launch
    Pre-requisite: Global Policy Report available
    Obj: In-country feasibility / Dev. of specific training materials
    Milestone: Getting on Global Fund list / Supply chain for initial demand
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: LAMP: high throughput. LAMP kit for simplified, high throughput malaria detection using whole blood or dried blood spots. Qualitative results. 96 well format for population screening. FIND, Porvair Sciences, 42 Technology, London Hospital for Tropical Diseases.

Illumigene Malaria

Malaria

Update Date: 15.11.15
  • Company Name: Meridian Bioscience, Inc.
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: PvA: P. vivax (acute)
  • Pathway Status: 6-Country pre-launch
    Pre-requisite: Global Policy Report available
    Obj: In-country feasibility / Dev. of specific training materials
    Milestone: Getting on Global Fund list / Supply chain for initial demand
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: LAMP: low throughput. Malaria LAMP assay for illumigene benchtop system, quality assured, simple molecular detection, qualitative results.

Rapid Assessment of Malaria (RAM)

Malaria

Update Date: 15.11.15
  • Company Name: Disease Diagnostic Group, Inc.
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Dx Assay
  • Technology Type: Spectroscopy
  • Biomarker Type: Metabolite
  • TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: POC Hemozoin detection. Portable (2 x 3 x 4 inches), rapid device using disposable plastic cuvettes.

Magneto-optical Device (MOD)

Malaria

Update Date: 15.11.15
  • Company Name: Meditopian LLC and Case Western Reserve University
  • Company Size: Pre-Company
    No legal entity
  • Product Type: Dx Assay
  • Technology Type: Spectroscopy
  • Biomarker Type: Metabolite
  • TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark: POC Hemozoin detection. Portable, rapid device using a reader and disposable cuvette.

Transdermal detection of nanobubbles.

Malaria

Update Date: 15.11.15
  • Company Name: Rice University, Masimo
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Spectroscopy
  • Biomarker Type: Metabolite
  • TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: Transdermal Hemozoin detection. Device-based, transdermal detection of hemozoin on reagentless system.

Hemozoin detection device.

Malaria

Update Date: 15.11.15
  • Company Name: Budapest University of Technology and Economics
  • Company Size: Pre-Company
    No legal entity
  • Product Type: Platform
  • Technology Type: Spectroscopy
  • Biomarker Type: Metabolite
  • TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: Hemozoin detection device. High-sensitivity diagnosis of malaria via magnetically induced linear dichroism.

Autoscope

Malaria

Update Date: 15.11.15
  • Company Name: Global Good Fund at Intellectual Ventures
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: Microscopy
  • Biomarker Type: Whole bug
  • TPP: PvA: P. vivax (acute)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: NA
  • Funders: Global Good
  • FIND Portfolio: No
  • Remark: Automated computer assisted microscopy. Reads Giemsa-stained blood samples. Speciates, quantitative results.

xRapid-Malaria

Malaria

Update Date: 15.11.15
  • Company Name: xRapid
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Adjunct tool
  • Technology Type: Microscopy
  • Biomarker Type: Whole bug
  • TPP: PvA: P. vivax (acute)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: Cell phone based microscopy.

NA

Malaria

Update Date: 15.11.15
  • Company Name: Indian Institute of Science
  • Company Size: Pre-Company
    No legal entity
  • Product Type: Dx Assay
  • Technology Type: Microscopy
  • Biomarker Type: Whole bug
  • TPP: PvA: P. vivax (acute)
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: Microfluidic cartridge processes samples, optical reader and image processing software.

Attenuated total reflection-fourier transform infrared spectroscopy

Malaria

Update Date: 15.11.15
  • Company Name: Monash University, University of Melbourne
  • Company Size: Pre-Company
    No legal entity
  • Product Type: Dx Assay
  • Technology Type: Spectroscopy
  • Biomarker Type: Whole bug
  • TPP: PvA: P. vivax (acute)
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: NA
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: POC spectroscopy device. Portable device based on attenuated total reflection-fourier transform infrared spectroscopy. Pilot study in Thailand.

ID-FISH Plasmodium Genus Test Kit; ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

Malaria

Update Date: 15.06.14
  • Company Name: ID-FISH Technology Inc.
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Adjunct tool
  • Technology Type: Microscopy
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: Fluorescent probes that bind with parasite RNA causing malaria-infected cells to fluoresce when viewed under a fluorescent microscope.

Malaria serology ELISA

Malaria

Update Date: 15.02.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody+Antigen
  • TPP: PvB1/PvB2: P. vivax (subpatent)
  • Pathway Status: 7-Country adoption
    Milestone: Diagnostic algorithm or Country policy change
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: ELISA tests that detect antibodies associated with Plasmodium infection

Malaria serology RDT

Malaria

Update Date: 15.02.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody+Antigen
  • TPP: PvB1/PvB2: P. vivax (subpatent)
  • Pathway Status: 7-Country adoption
    Milestone: Diagnostic algorithm or Country policy change
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: Lateral flow immuno-chromatographic antibody-detection tests

Sero-surveillance for Pv.

Malaria

Update Date: 15.05.17
  • Company Name: Walter and Eliza Hall Institute, Institute Pasteur, FIND
  • Company Size: Pre-Company
    No legal entity
  • Product Type: Adjunct tool
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: PvB1/PvB2: P. vivax (subpatent)
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: NA
  • Funders: GHIT
  • FIND Portfolio: Yes
  • Remark: Serology: high throughput. High throughput, multiplex ELISA or other platform that detects antibodies marking recent Pv infection, for use in surveillance.

Sero-test and treat for Pv.

Malaria

Update Date: 15.05.17
  • Company Name: Walter and Eliza Hall Institute, Institute Pasteur, FIND
  • Company Size: Pre-Company
    No legal entity
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: PvB1/PvB2: P. vivax (subpatent)
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders: GHIT
  • FIND Portfolio: Yes
  • Remark: POC Serology. POC test that detects antibodies indicating recent exposure (about 9 months) to Pv, used to inform radical cure treatment.

Serology RDT

Malaria

Update Date: 15.05.17
  • Company Name: Consortium
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Adjunct tool
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: PvB1/PvB2: P. vivax (subpatent)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders: Global Good
  • FIND Portfolio: No
  • Remark: Advanced lateral flow assay and reader system that detects nanoparticles tagged to key serological biomarkers of malaria.

Serology RDT

Malaria

Update Date: 15.05.17
  • Company Name: Burnet Institute; Nanjing Bio Point
  • Company Size: NA
  • Product Type: Adjunct tool
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: PvB1/PvB2: P. vivax (subpatent)
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: Lateral flow immuno-chromatographic antibody-detection tests; quantitative output.

Serology assay for recent exposure in pregnant women.

Malaria

Update Date: 15.05.17
  • Company Name: IS Global
  • Company Size: Pre-Company
    No legal entity
  • Product Type: Adjunct tool
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Other
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: A surveillance tool detecting antibodies against VAR2CSA.

Battery/solar powered simple imaging cytometer.

Malaria

Update Date: 15.11.15
  • Company Name: One world Cytometry Inc.
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Platform
  • Technology Type: Immunoassay
  • Biomarker Type: Metabolite
  • TPP: Other
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark:

miLab Malaria

Malaria

Update Date: 22.12.17
miLab Malaria
  • Company Name: noul Inc.
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: Microscopy
  • Biomarker Type: Whole bug
  • TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: No
  • Funders: KOICA
  • FIND Portfolio: No
  • Remark: Automated POC microscopy platform integrating innovative Tubing-Free Lab on a Chip, mobile imaging platform, and artificial intelligence for image analysis.

Pinpoint Malaria Meter

Malaria

Update Date: 26.04.18
Pinpoint Malaria Meter
  • Company Name: Pinpoint Science Inc.
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigen
  • TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark: IVD solution that will provide detection of malaria (HRP2) in seconds using either saliva or fingerprick blood sample using a low-cost reader, disposable cartridges, and a mobile app, allowing data to be captured in a cloud repository. The product is based on a novel nanosensor technology developed by University of California/Santa Cruz.

ImmunoPOC

Fever

Update Date: 27.10.2017
  • Company Name: Memed Diagnostics
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: Bacterial versus non-bacterial differentiation test for fever
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: ImmunoPoC relies on measurements of the immune response to diagnose the source of infection.

FebriDx

Fever

Update Date: 27.10.2017
  • Company Name: RPS Diagnostics
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: Bacterial versus non-bacterial differentiation test for fever
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

Malaria/CRP duo test

Fever

Update Date: 27.10.2017
  • Company Name: SD Biosensor
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: Bacterial versus non-bacterial differentiation test for fever
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: This is a a combo test for Malaria and non-Malaria fever

BD Veritor POC Fever Triage Assay

Fever

Update Date: 27.10.2017
  • Company Name: Becton&Dickinson
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: Bacterial versus non-bacterial differentiation test for fever
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark:

Landscape CRP Tests

Fever

Update Date: 07.09.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: Bacterial versus non-bacterial differentiation test for fever
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: Landscape of CRP tests coordinated by FIND.

Landscape PCT Tests

Fever

Update Date: 07.09.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: Bacterial versus non-bacterial differentiation test for fever
  • Pathway Status: 4-Regulatory achieved
    Pre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: Landscape of PCT tests coordinated by FIND.

HostDx Fever

Fever

Update Date: 08.03.18
  • Company Name: Inflammatix, Inc.
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Bacterial versus non-bacterial differentiation test for fever
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: A molecular technology measuring the expression levels of numerous host immune genes, and then applying proprietary algorithms to produce rapid, clinically actionable results.

ASPIRE

Malaria

Update Date: 22.03.18
  • Company Name: VisionQuest Biomedical LLC
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: Imaging
  • Biomarker Type: Other
  • TPP: Other
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark: A malarial retinopathy detection system consisting of an automatic malarial retinopathy detection software integrated with low-cost and portable retinal camera designed for use in clinical settings. The ASPIRE system aims to augment the current cerebral malaria diagnostic standard.

SD BIOLINE HAT

HAT

Update Date: 09.02.18
  • Company Name: Standard Diagnostics/Abbott
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Screening
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders: Multiple
  • FIND Portfolio: Yes
  • Remark: Screening test including 2 native antigens

HAT Sero K-SeT

HAT

Update Date: 09.02.18
  • Company Name: Coris BioConcept
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Screening
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

SD BIOLINE HAT 2.0

HAT

Update Date: 09.02.18
  • Company Name: Standard Diagnostics/Abbott
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Screening
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders: Multiple
  • FIND Portfolio: Yes
  • Remark: Screening test including 2 recombinant antigens

Loopamp Trypanosoma brucei Detection Kit

HAT

Update Date: 09.02.18
  • Company Name: Eiken Chemical Co., Ltd
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Screening
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: Yes
  • Funders: Multiple
  • FIND Portfolio: Yes
  • Remark:

SD BIOLINE HAT/Malaria Duo

HAT

Update Date: 09.02.18
  • Company Name: Standard Diagnostics/Abbott
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody+Antigen
  • TPP: Screening/Diagnosis
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders: Multiple
  • FIND Portfolio: Yes
  • Remark: For simultaneous screening for g-HAT and diagnosis of P. falciparum malaria

2nd generation RDT (name to be confirmed)

HAT

Update Date: 24.02.18
  • Company Name: Coris BioConcept
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Screening
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

iELISA (immune trypanolysis)

HAT

Update Date: 24.02.18
  • Company Name: Institute of Tropical Medicine, Antwerp
  • Company Size: Research Institute
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Other
  • TPP: Screening
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Lab
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Loopamp Trypanosoma cruzi Detection Kit

Chagas

Update Date: 17.08.17
  • Company Name: Eiken Chemical Co., Ltd
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Congenital (acute) Chagas disease
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: Yes
  • Remark: LAMP test developed by FIND, EIKEN and other partners

LAMP Chagas (not defined)

Chagas

Update Date: 20.02.18
  • Company Name: Multiple
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Congenital (acute) Chagas disease
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: NA
  • Funders: Ministerio de Ciencia, Tecnología, e Innovación Productiva
  • FIND Portfolio: No
  • Remark: LAMP test develped by a Consortium: CONICET - UNIFARMA S. A. - LABORATORIO PABLO CASSARÁ S. A

CHUNAP (not defined)

Chagas

Update Date: 17.08.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: Congenital (acute) Chagas disease
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: NA
  • Funders: National Institute of Health
  • FIND Portfolio: No
  • Remark: Antigen detection test developed by the University of California and other academic groups.

SAPA (not defined)

Chagas

Update Date: 19.02.18
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: Congenital (acute) Chagas disease
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: ELISA to detect T. cruzi Shed Acute Phase Antigen (SAPA) developed by the Instituto Nacional de Parasitología (INP) Dr. M. Fatala Chaben and other academic groups

InfYnity Chagas ToC (not defined)

Chagas

Update Date: 22.08.17
  • Company Name: InfYnity Biomarkers
  • Company Size: Micro
    < 10 FTE | ≤ EUR 2 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Test of cure
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: No
  • Funders:
  • FIND Portfolio: No
  • Remark: ELISA & Multiplex developped for diagnosis and treatment monitoring

NA

Chagas

Update Date: 22.08.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Other
  • TPP: Test of cure
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: Several academic groups are working on biomarkers to be used to monitor treatment efficacy

f-TLC

Buruli ulcer

Update Date: 28.08.17
  • Company Name: Harvard University
  • Company Size: Research Institute
  • Product Type: Dx assay
  • Technology Type: Other
  • Biomarker Type: Other
  • TPP: Diagnosis
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: No
  • Funders: FIND and others
  • FIND Portfolio: Yes
  • Remark: The target is mycolactone, a toxin. Polyketide-derived macrolide. f-TLC is a home brewed method developed by Harvard University that WHO has adopted for evaluation and implementation at diszrict hospital level in seleceted sites, while other tests are developed.

BUD-LAMP (not defined)

Buruli ulcer

Update Date: 28.08.17
  • Company Name: DITM/KUM, NMIMR, Optigene
  • Company Size: Research Institute
  • Product Type: Dx assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Diagnosis
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders: UBS-Optimus Foundation, Anesvad
  • FIND Portfolio: Yes
  • Remark:

BU-RDT (not defined)

Buruli ulcer

Update Date: 28.08.17
  • Company Name: Standard Diagnostics/Abbott
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Protein
  • TPP: Diagnosis
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders: UBS-Optimus Foundation, Anesvad, Swiss Agency for Development and Cooperation, German Federal Ministry of Education and Research
  • FIND Portfolio: Yes
  • Remark:

BU ELONA (not defined)

Buruli ulcer

Update Date: 08.09.17
  • Company Name: Aptagen LLC
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx assay
  • Technology Type: Other
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Diagnosis
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: No
  • Funders: BMGF
  • FIND Portfolio: No
  • Remark: Other academic partners are also involved.

Loopamp Leishmania Detection Kit

Leishmaniasis

Update Date: 28.08.17
  • Company Name: Eiken Chemical Co., Ltd
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Diagnosis
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: Yes
  • Funders: German Federal Ministry of Education and Research
  • FIND Portfolio: Yes
  • Remark:

Leishmaniasis-RDT (not defined)

Leishmaniasis

Update Date: 28.08.17
  • Company Name: Multiple
  • Company Size: NA
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigen
  • TPP: Diagnosis
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: NA
  • Funders: Swiss Agency for Development and Cooperation
  • FIND Portfolio: Yes
  • Remark: This a very early stage project, with a panel of mAbs identified for characterization. Best mAb pairs for prototype RDT development have not been selected yet. This test is envisioned to have an additional application for a test of cure.

Leismaniasis IgG1-RDT (not defined)

Leishmaniasis

Update Date: 28.08.17
  • Company Name: Coris BioConCept
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Test of cure
  • Pathway Status: 2-Development
    Pre-requisite: Dev. under QMS / Analytical data available
    Obj: Assay optimization / Manufacturability assessment
    Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders: European Commission
  • FIND Portfolio: No
  • Remark: LSHTM is also involved in the project.

LD RPA (not defined)

Leishmaniasis

Update Date: 28.08.17
  • Company Name: TwistDx
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Diagnosis
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders: WHO/TDR
  • FIND Portfolio: No
  • Remark: Other research institutes are also involved.

RPA-LF (not defined)

Leishmaniasis

Update Date: 28.08.17
  • Company Name: TwistDx
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx assay
  • Technology Type: PCR (Isothermal)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Diagnosis
  • Pathway Status: 1-Concept
    Pre-requisite: Needs assessed / PRD available
    Obj: Show probability of success
    Milestone: Prototype but not design lock
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: NA
  • Funders: AFHSC/GEIS (US)
  • FIND Portfolio: No
  • Remark: Other research institutes are also involved.

CL Detect Rapid Test for Cutaneous Leishmaniasis

Leishmaniasis

Update Date: 08.09.17
  • Company Name: InBios International
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigen
  • TPP: Diagnosis
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Leishmania OligoC-TesT

Leishmaniasis

Update Date: 18.03.18
  • Company Name: Coris BioConcept
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Diagnosis
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Lab
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark:

SD BIOLINE Leishmania Ab

Leishmaniasis

Update Date: 18.03.18
  • Company Name: Standard Diagnostics/Abbott
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Diagnosis
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

IT-Leish

Leishmaniasis

Update Date: 18.03.18
  • Company Name: BIO-RAD
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Diagnosis
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Kalazar Detect

Leishmaniasis

Update Date: 18.03.18
  • Company Name: InBios International
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Diagnosis
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Leishmania IgG/IgM Combo Rapid Test CE

Leishmaniasis

Update Date: 18.03.18
  • Company Name: CTK Biotech
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Diagnosis
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Leishmania Ab Rapid Test CE

Leishmaniasis

Update Date: 18.03.18
  • Company Name: CTK Biotech
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Diagnosis
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Leishmania Ab ELISA Test CE

Leishmaniasis

Update Date: 18.03.18
  • Company Name: CTK Biotech
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • TPP: Diagnosis
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L0-Community
    Minimally trained health worker | RDT
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

Katex

Leishmaniasis

Update Date: 18.03.18
  • Company Name: Kalon Biological Ltd.
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: Diagnosis
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L1-Microscopy Center
    Clinic staff | RDT, handheld instruments, battery operated C4
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: The antigen is a carbohydrate.

VL ELISA

Leishmaniasis

Update Date: 18.03.18
  • Company Name: Kalon Biological Ltd.
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: Diagnosis
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: Yes
  • Remark: The antigen is a carbohydrate.

Leishmania Antigen Detect ELISA

Leishmaniasis

Update Date: 21.03.18
  • Company Name: InBios International
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antigens
  • TPP: Diagnosis
  • Pathway Status: 3-Validation
    Pre-requisite: Design locked product or near / Pilot line for manufacturing
    Obj: Laboratory/clinical validation
    Milestone: Statistically powered studies on patient samples / Manufacturing in place
    URL: www.tbdxpathway.org
  • Lowest Health Level: L2-District Lab
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:

STAT-NAT Leishmania

Leishmaniasis

Update Date: 18.03.18
  • Company Name: Sentinel Diagnostics
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Diagnosis
  • Pathway Status: 8-Scale-up & Impact
    Pre-requisite: Diagnostic algorithm or Country policy change
    Milestone: 1 peer-reviewed cost-effectivenees or impact study
    URL: www.tbdxpathway.org
  • Lowest Health Level: L3-Reference Lab
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark:
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