Dx Pipeline Timeline

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

Mycobacterial cu...

Multiple

Q1
2007

GenoType MTBDRpl...

Hain Lifescience...

Q2
2008

LED Microscopy

Multiple

Malaria RDT

Multiple

Q2

Xpert MTB/RIF

Cepheid

Q4
2010

Loopamp Trypanos...

Eiken Chemical C...

Q3
2011

SD BIOLINE HAT

Standard Diagnos...

Q1
2012

GenoType MTBDRsl...

Hain Lifescience...

Q1

HAT Sero K-SeT

Coris BioConcept

Q2
2013

Determine TB LAM...

Alere Inc.

GenoType MTBDRpl...

Hain Lifescience...

NTM+MDRTB

Nipro

Q4
2015

GenoType MTBDRsl...

Hain Lifescience...

Q2

Loopamp MTBC ass...

Eiken Chemical C...

Q3
2016

Xpert MTB/RIF Ul...

Cepheid

Q3
2017

SD BIOLINE HAT 2...

Standard Diagnos...

Loopamp Leishman...

Eiken Chemical C...

Q2

Molecular Stool

Multiple

Q4
2018

Xpert XDR

Cepheid

Omni

Cepheid

Sensitive LAM

Fujifilm

Sensitive LAM

SD BIOLINE HAT/M...

Standard Diagnos...

Q2

RealTime MTB RIF...

Abbott Laborator...

BD MAX MDR-TB

Becton-Dickinson

MGIT-Bedaquiline...

Becton-Dickinson

FluoroType MTBDR...

Hain Lifescience...

Cobas MTB-RIF/IN...

Roche

Q3

SemanticMD AI fo...

SemanticMD

RiView-TB

ChironX

Qure Chest X-ray...

Qure.ai

CAD4TB

Delft Imaging Sy...

Loopamp MALARIA ...

Eiken Chemical C...

BUD-LAMP (not de...

DITM/KUM, NMIMR,...

Q4
2019

Incipient TB Ass...

Abbott Laborator...

T-cell Immune Pr...

Becton-Dickinson

FluoroType MTBXD...

Hain Lifescience...

Low-cost Easy to...

Multiple

RTT TB

Lophius Bioscien...

QFT-Predict

Qiagen

QIA-TB Signature

Qiagen

Q2
2020

BU-RDT (not defi...

Standard Diagnos...

Leishmaniasis-RD...

Multiple

Q2

Blood host marke...

Multiple

MTB-antigens POC...

Multiple

Q4
2021

Blood/urine cfDN...

Multiple

Q4
2022

RealTime MTB RIF/INH

Tuberculosis

Date of Entry: Q3-2019
  • 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

Date of Entry: Q2-2020
  • 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.

SemanticMD AI for TB

Tuberculosis

Date of Entry: Q4-2019
  • Company Name: SemanticMD
  • 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: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: The company develops AI for TB to improve the quality and efficiency of chest X-ray screening programs.

RiView-TB

Tuberculosis

Date of Entry: Q4-2019
  • Company Name: ChironX
  • 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: Develop a CAD solution for TB dx from chest X-rays. Formerly known as Advenio Tecnosys.

TruArray MDR-TB

Tuberculosis

Date of Entry:
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

Date of Entry:
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

Date of Entry: Q4-2015
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry: Q3-2019
  • 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

Date of Entry: Q1-2007
  • 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

Date of Entry: Q3-2019
  • 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

Date of Entry: Q2-2020
  • 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

Date of Entry: Q1-2007
  • 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

Date of Entry: Q4-2018
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

Date of Entry:
  • 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

Date of Entry: Q4-2019
  • 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

Date of Entry:
  • 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

Date of Entry: Q2-2019
  • 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

Date of Entry: Q2-2019
  • 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

Date of Entry: Q3-2017
  • 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

Date of Entry: Q4-2010
  • 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

Date of Entry: Q4-2019
  • 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

Date of Entry: Q4-2019
  • 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

Date of Entry:
  • 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

Date of Entry: Q3-2016
  • 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

Date of Entry:
  • 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

Date of Entry: Q2-2019
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

Date of Entry:
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

Date of Entry: Q2-2020
  • 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

Date of Entry: Q3-2019
  • 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

Date of Entry:
  • 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

Date of Entry: Q2-2016
  • 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

Date of Entry: Q1-2013
  • 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

Date of Entry: Q4-2015
  • 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

Date of Entry: Q2-2008
  • 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

Date of Entry:
  • 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

Date of Entry: Q2-2020
  • 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

Date of Entry:
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.

AdvanSure MDR-TB GenoBlot Assay

Tuberculosis

Date of Entry:
  • 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

Date of Entry:
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

Date of Entry:
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

Date of Entry: Q2-2020
  • 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

Date of Entry:
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

Date of Entry:
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.

LabChip-based Rapid POCT

Tuberculosis

Date of Entry:
  • 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

Date of Entry:
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

Date of Entry:
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

Date of Entry:
  • 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

Date of Entry: Q4-2015
  • 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

Date of Entry:
  • 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

Date of Entry: Q2-2020
  • 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

Date of Entry: Q2-2020
  • 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

Date of Entry:
  • 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

Date of Entry:
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

Date of Entry: Q4-2019
  • 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

Date of Entry:
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

Date of Entry: Q3-2019
  • 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

Date of Entry: Q1-2007
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
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

Date of Entry:
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

Date of Entry: Q1-2007
  • 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

Date of Entry: Q1-2007
  • 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

Date of Entry:
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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry: Q2-2010
  • 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

Date of Entry: Q4-2018
  • 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, Baylor College of Medecine, Others

NA-NOSE

Tuberculosis

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry: Q4-2021
  • 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

Date of Entry: Q4-2021
  • 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: NanoPin & ASU, Tufts Univ., Others

Blood/urine cfDNA POC assays

Tuberculosis

Date of Entry: Q4-2022
  • 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

Date of Entry:
  • 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

Date of Entry: Q1-2007
  • 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

Molecular Bacterial Load Assay (MBLA)

Tuberculosis

Date of Entry:
  • Company Name: LifeArc / University of St Andrews Infection Group
  • Company Size: NA
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • TPP: Treatment monitoring or 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: L3-Reference Laboratory
    Hospital staff | Large footprint & Complex Instruments
  • Certified QMS: NA
  • Funders:
  • FIND Portfolio: No
  • Remark: The test will use molecular methods to count the number of live bacteria. It is based on the RT-qPCR enumeration of MTB 16S rRNA from viable tubercle bacilli.

mfloDx MDR/XDR-TB

Tuberculosis

Date of Entry:
mfloDx MDR/XDR-TB
  • Company Name: EMPE Diagnostics
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: PCR (LPA)
  • 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: No
  • Funders:
  • FIND Portfolio: No
  • Remark: This test can detect the presence of the TB-causative organism, Mycobacterium tuberculosis, and its susceptibility or resistance to most of the antibiotics used for TB treatment. This combinatorial molecular diagnostic test produces visual signals on lateral flow cassettes corresponding to the respective genotype-tags on lateral flow strips, in 70 min. 

CYCLE MDR-TB

Tuberculosis

Date of Entry:
  • Company Name: FRIZ Biochem GmbH
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 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: 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 molecular test is running on CYCLE platform that is built around a disposable lab-on-a-chip cartridge with integrated circuit based micro-electrode-array for the automated detection of a broad range and number of nucleic acid sequences.

TB dx (not defined)

Tuberculosis

Date of Entry:
  • Company Name: Unima
  • Company Size: Small
    < 50 FTE | ≤ EUR 10 m
  • Product Type: Dx Assay
  • Technology Type: Immunoassay
  • Biomarker Type: Antibody
  • 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: Paper device for the detection of TB using blood as a sample.

Not defined

Tuberculosis

Date of Entry:
  • Company Name: Mobidiag
  • Company Size: Medium
    < 250 FTE | ≤ EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Microarray)
  • 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: L2-District Lab/Hospital
    Lab technician | RDT, molecular tests, ELISA C7
  • Certified QMS: Yes
  • Funders:
  • FIND Portfolio: No
  • Remark: The molecular assay will run on Novodiag that is a molecular diagnostics solution allowing fully automated detection in combining real-time PCR and microarray technologies. Direct analysis is enabled by a disposable cartridge.

Not defined

Tuberculosis

Date of Entry:
  • Company Name: Biomérieux/Bioaster
  • Company Size: Large
    ≥250 FTE | > EUR 50 m
  • Product Type: Dx Assay
  • Technology Type: PCR (Conventional)
  • Biomarker Type: Nucleic Acid (RNA, DNA)
  • 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: The Francis Crick Institute and the University of Leicester have partnered with BioMérieux and Bioaster to develop a diagnostic assay on BioMérieux's BioFire FilmArray platform based on a 20-gene biosignature.

Malaria RDT

Malaria

Date of Entry: Q2-2010
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry: Q4-2019
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry: Q4-2024
  • 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

Date of Entry: Q4-2024
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
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

Date of Entry:
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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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: 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: Yes
  • Remark: This is a a combo test for Malaria and non-Malaria fever

BD Veritor POC Fever Triage Assay

Fever

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry: Q1-2012
  • 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

Date of Entry: Q2-2013
  • 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

Date of Entry: Q2-2018
  • 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

Date of Entry: Q3-2011
  • 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

Date of Entry: Q2-2019
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry: Q4-2019
  • 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

Date of Entry: Q2-2021
  • 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

Date of Entry:
  • 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

Date of Entry: Q2-2018
  • 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

Date of Entry: Q2-2021
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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

Date of Entry:
  • 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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