Dx Pipeline Status
Disease
- Show All
- Tuberculosis
- Malaria
- Fever
- HAT
- Chagas
- Buruli ulcer
- Leishmaniasis
TPP - Select Disease first
- Show All
- A rapid biomarker-based non-sputum-based test for detecting TB
- Community-based triage or referral test for identifying people suspected of having TB
- Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
- Next-generation drug-susceptibility testing at microscopy centres
- Centralized drug susceptibility testing (DST)
- Test for incipient TB
- Treatment monitoring or test of cure
- Sample transport solution
- Other
- Pf: P. falciparum (subpatent)
- PvA: P. vivax (acute)
- PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
- PvB1/PvB2: P. vivax (subpatent)
- Other
- Bacterial versus non-bacterial differentiation test for fever
- Other
- Screening
- Screening/Diagnosis
- Congenital (acute) Chagas disease
- Test of cure
- Diagnosis
- Diagnosis
- Test of cure
FIND Portfolio
- Show All
- Yes
- No
- In discussion
Health Level
- Show All
- L0-Community
- L1-Microscopy Center
- L2-District Lab/Hospital
- L3-Reference Laboratory
- NA
Company Size
- Show All
- Pre-Company
- Micro
- Small
- Medium
- Large
- Research Institute
- Other
- NA
Tuberculosis
Malaria
Fever
HAT
Chagas
Buruli ulcer
Leishmaniasis
RealTime MTB RIF/INH
Tuberculosis
Update Date: 25.06.18
- Company Name: Abbott Laboratories
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 5-WHO evaluationObj: Evaluation or demonstration studies to inform WHO policy
Milestone: WHO endorsement / Pre-qualified products
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: This assay runs on m2000sp and m2000rt from Abbott.
Incipient TB Assay
Tuberculosis
Update Date: 02.10.17
- Company Name: Abbott Laboratories
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: NA
- Biomarker Type: NA
- TPP: Test for incipient TB
- Pathway Status: 1-ConceptPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: This assay runs on m2000sp and m2000rt from Abbott.
RiView-TB
Tuberculosis
Update Date: 20.06.17
- Company Name: Advenio TecnoSys
- Company Size: NA
- Product Type: Adjunct tool
- Technology Type: Imaging
- Biomarker Type: Other
- TPP: Community-based triage or referral test for identifying people suspected of having TB
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark:
TruArray MDR-TB
Tuberculosis
Update Date: 28.11.17
- 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-DevelopmentPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: This assay runs on TruDx3000 from Akonni.
TruArray XDR-TB
Tuberculosis
Update Date: 28.11.17
- 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-DevelopmentPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: This assay runs on TruDx3000 from Akonni.
Determine TB LAM Ag
Tuberculosis
Update Date: 20.06.17
- Company Name: Alere Inc.
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: A rapid biomarker-based non-sputum-based test for detecting TB
- Pathway Status: 6-Country pre-launchPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
INFINITI MDR-TB
Tuberculosis
Update Date: 20.06.17
- Company Name: AutoGenomics
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 3-ValidationPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: RUO Product.
TB Resistance Module series
Tuberculosis
Update Date: 20.06.17
- Company Name: Autoimmun Diagnostika (AID)
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: PCR (LPA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
BreathTest
Tuberculosis
Update Date: 20.06.17
- Company Name: Avisa Pharma Inc.
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Dx Assay
- Technology Type: Spectroscopy
- Biomarker Type: Metabolite
- TPP: Community-based triage or referral test for identifying people suspected of having TB
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark:
BD MAX MDR-TB
Tuberculosis
Update Date: 06.08.18
- Company Name: Becton-Dickinson
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 5-WHO evaluationObj: Evaluation or demonstration studies to inform WHO policy
Milestone: WHO endorsement / Pre-qualified products
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: The assay runs on the BD MAX System which is a fully-integrated, automated platform that performs nucleic acid extraction and real-time PCR.
BACTEC MGIT System
Tuberculosis
Update Date: 20.06.17
- Company Name: Becton-Dickinson
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Platform
- Technology Type: Growth based
- Biomarker Type: Whole bug
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 8-Scale-up & ImpactPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
MGIT-Bedaquiline&Delamanid
Tuberculosis
Update Date: 25.06.18
- Company Name: Becton-Dickinson
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: Growth based
- Biomarker Type: Whole bug
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 5-WHO evaluationObj: Evaluation or demonstration studies to inform WHO policy
Milestone: WHO endorsement / Pre-qualified products
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
T-cell Immune Profiling
Tuberculosis
Update Date: 02.10.17
- Company Name: Becton-Dickinson
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: NA
- Biomarker Type: NA
- TPP: Test for incipient TB
- Pathway Status: 1-ConceptPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
BacT/ALERT 3D
Tuberculosis
Update Date: 20.06.17
- Company Name: Biomérieux
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Platform
- Technology Type: Growth based
- Biomarker Type: Whole bug
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 8-Scale-up & ImpactPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
AccuPower TB&MDR Real-Time PCR
Tuberculosis
Update Date: 27.11.17
- 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 achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: This PCR product is closed system on ExiStation Molecular Diagnostics System of BIONEER
PoC
Tuberculosis
Update Date: 27.11.17
- Company Name: Bioneer
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Platform
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Next-generation drug-susceptibility testing at microscopy centres
- Pathway Status: 2-DevelopmentPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
AccuPower XDR-TB Real-Time PCR
Tuberculosis
Update Date: 27.11.17
- Company Name: Bioneer
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 3-ValidationPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: This product is closed system on ExiStation Molecular Diagnostics System of Bioneer
Tuberculosis Drug Resistance Detection Array Kit
Tuberculosis
Update Date: 20.06.17
- Company Name: CapitalBio Technology
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Xpert XDR
Tuberculosis
Update Date: 20.06.17
- Company Name: Cepheid
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Next-generation drug-susceptibility testing at microscopy centres
- Pathway Status: 2-DevelopmentPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
Omni
Tuberculosis
Update Date: 06.04.17
- Company Name: Cepheid
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Platform
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Next-generation drug-susceptibility testing at microscopy centres
- Pathway Status: 2-DevelopmentPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
Xpert MTB/RIF Ultra
Tuberculosis
Update Date: 20.06.17
- Company Name: Cepheid
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Next-generation drug-susceptibility testing at microscopy centres
- Pathway Status: 6-Country pre-launchPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
Xpert MTB/RIF
Tuberculosis
Update Date: 20.06.17
- Company Name: Cepheid
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Next-generation drug-susceptibility testing at microscopy centres
- Pathway Status: 8-Scale-up & ImpactPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
Qure Chest X-rays for TB
Tuberculosis
Update Date: 19.04.18
- Company Name: Qure.ai
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Adjunct Tool
- Technology Type: Imaging
- Biomarker Type: Other
- TPP: Community-based triage or referral test for identifying people suspected of having TB
- Pathway Status: 5-WHO evaluationObj: Evaluation or demonstration studies to inform WHO policy
Milestone: WHO endorsement / Pre-qualified products
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: a fully automated robust deep learning algorithm that detects abnormal findings on chest X–ray and combines these findings to detect abnormalities suggestive of pulmonary tuberculosis
CAD4TB
Tuberculosis
Update Date: 19.04.18
- Company Name: Delft Imaging Systems
- Company Size: NA
- Product Type: Adjunct Tool
- Technology Type: Imaging
- Biomarker Type: Other
- TPP: Community-based triage or referral test for identifying people suspected of having TB
- Pathway Status: 5-WHO evaluationObj: Evaluation or demonstration studies to inform WHO policy
Milestone: WHO endorsement / Pre-qualified products
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: No
- Funders:
- FIND Portfolio: Yes
- Remark: Software has been certified in 2015 (CE-mark)
OMNIgene SPUTUM
Tuberculosis
Update Date: 19.04.18
- Company Name: DNA Genotek, Inc.
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Adjunct Tool
- Technology Type: NA
- Biomarker Type: NA
- TPP: Sample transport solution
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: OMNIgene SPUTUM is a non-toxic and highly stable reagent that liquefies and decontaminates sputum samples at the point-of-collection or in the lab while preserving MTB viability for at least 8 days at ambient temperatures.
Loopamp MTBC assay
Tuberculosis
Update Date: 20.06.17
- Company Name: Eiken Chemical Co., Ltd
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
- Pathway Status: 6-Country pre-launchPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
INNO-LiPA Rif.TB
Tuberculosis
Update Date: 26.07.17
- Company Name: Fuji-Rebio Europe
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (LPA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 3-ValidationPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Sensitive LAM
Tuberculosis
Update Date: 19.04.18
- 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-ValidationPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders: GHIT
- FIND Portfolio: Yes
- Remark:
Genedrive MTB
Tuberculosis
Update Date: 03.11.17
- 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-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
FluoroType MTBXDR VER 1.0
Tuberculosis
Update Date: 29.09.17
- Company Name: Hain Lifescience GmbH
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 2-DevelopmentPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
FluoroType MTBDR VER 1.0
Tuberculosis
Update Date: 25.06.18
- Company Name: Hain Lifescience GmbH
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 5-WHO evaluationObj: Evaluation or demonstration studies to inform WHO policy
Milestone: WHO endorsement / Pre-qualified products
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: The amplification and detection are performed in the FluoroCycler 96.
FluoroType MTB VER 1.0
Tuberculosis
Update Date: 20.06.17
- Company Name: Hain Lifescience GmbH
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Other - Centralized Molecular no DST
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
GenoType MTBDRsl VER 2.0
Tuberculosis
Update Date: 20.06.17
- Company Name: Hain Lifescience GmbH
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (LPA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 8-Scale-up & ImpactPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
GenoType MTBDRsl VER 1.0
Tuberculosis
Update Date: 20.06.17
- Company Name: Hain Lifescience GmbH
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (LPA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 8-Scale-up & ImpactPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
GenoType MTBDRplus VER 2.0
Tuberculosis
Update Date: 20.06.17
- Company Name: Hain Lifescience GmbH
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (LPA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 8-Scale-up & ImpactPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
GenoType MTBDRplus VER 1.0
Tuberculosis
Update Date: 20.06.17
- Company Name: Hain Lifescience GmbH
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (LPA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 8-Scale-up & ImpactPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
ID-FISH assay
Tuberculosis
Update Date: 20.06.17
- Company Name: ID-FISH Technology Inc.
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Adjunct Tool
- Technology Type: Microscopy
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
- Pathway Status: 3-ValidationPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Low-cost Easy to Use NGS
Tuberculosis
Update Date: 25.06.18
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Sequencing
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 1-ConceptPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: Illumina, Genoscreen, Tgen, BMS, Longhorn, ...
InSilixa HYDRA-1k
Tuberculosis
Update Date: 08.01.18
- 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-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: This is a high-multiplex NAAT CMOS biochip platform technology that will support TB-XDR diagnosis in addition to other infectious diseases.
TBDx System project
Tuberculosis
Update Date: 20.06.17
- Company Name: Keck Graduate Institute (KGI)
- Company Size: Not A Commercial Entity
- Product Type: Dx Assay
- Technology Type: PCR (LPA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark:
AdvanSure MDR-TB GenoBlot Assay
Tuberculosis
Update Date: 20.06.17
- Company Name: LG Life Sciences
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (LPA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 3-ValidationPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
PrimeSuite TB
Tuberculosis
Update Date: 20.06.17
- 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-ValidationPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: PrimeSuite TB is an end-to-end solution for active tuberculosis infection screening and genetic analysis of drug resistance. It works on most open platform Real-time PCR platforms and Next Generation sequencers, and can be integrated with many high throughput extraction systems.
PrimeStore MTM
Tuberculosis
Update Date: 20.06.17
- 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 achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: PrimeStore MTM is a solution for collection, transport, and storage of specimens for nucleic acid testing and analysis. It is also a system for short, medium, and long-term storage of samples.
RTT TB
Tuberculosis
Update Date: 20.06.17
- Company Name: Lophius Biosciences
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: NA
- Biomarker Type: NA
- TPP: Test for incipient TB
- Pathway Status: 2-DevelopmentPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Truenat MTB
Tuberculosis
Update Date: 20.06.17
- 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 achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L1-Microscopy CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: Chip-based Real Time micro PCR Tests, for automatic amplification and analysis of extracted nucleic acids with Truelab real time micro PCR analyzer & Trueprep sample prep device.
Truenat MTB RIF Dx
Tuberculosis
Update Date: 20.06.17
- 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 achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L1-Microscopy CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: Chip-based Real Time micro PCR Tests, for automatic amplification and analysis of extracted nucleic acids with Truelab real time micro PCR analyzer & Trueprep sample prep device.
NANO4Pathogen
Tuberculosis
Update Date: 20.06.17
- Company Name: Nano4Global
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Dx Assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Next-generation drug-susceptibility testing at microscopy centres
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark:
LabChip-based Rapid POCT
Tuberculosis
Update Date: 18.04.18
- Company Name: MicoBiomed
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Platform
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 2-DevelopmentPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: Development of an automated, fully integrated and portable sample-to-answer device.
UltraFast LabChip Real-time PCR - MDR-TB kit
Tuberculosis
Update Date: 18.04.18
- 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-DevelopmentPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: This molecular real-time PCR assay is running on the UltraFast Sample Prep & UltraFast LabChip Real-time PCR instruments.
BioNanoPore
Tuberculosis
Update Date: 20.06.17
- 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-ConceptPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
NS-POC TB Detector
Tuberculosis
Update Date: 20.06.17
- Company Name: NanoSynth
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Dx Assay
- Technology Type: Spectroscopy
- Biomarker Type: Metabolite
- TPP: Community-based triage or referral test for identifying people suspected of having TB
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark:
NTM+MDRTB
Tuberculosis
Update Date: 20.06.17
- Company Name: Nipro
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (LPA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 8-Scale-up & ImpactPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
LAM-ELISA
Tuberculosis
Update Date: 20.06.17
- Company Name: Otsuka Pharmaceutical Co., Ltd.
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: Treatment monitoring or test of cure
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
QFT-Predict
Tuberculosis
Update Date: 02.10.17
- Company Name: Qiagen
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: NA
- Biomarker Type: NA
- TPP: Test for incipient TB
- Pathway Status: 1-ConceptPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
QIA-TB Signature
Tuberculosis
Update Date: 02.10.17
- Company Name: Qiagen
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: NA
- Biomarker Type: NA
- TPP: Test for incipient TB
- Pathway Status: 1-ConceptPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
MTB drug-resistant Mutation Test Kits
Tuberculosis
Update Date: 20.06.17
- Company Name: QuanDx
- Company Size: Small< 50 FTE | ≤ EUR 10 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
QMAC DST
Tuberculosis
Update Date: 20.06.17
- 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-ValidationPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Q-POC TB/MDR TB
Tuberculosis
Update Date: 17.06.18
- Company Name: QuantuMDx
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Next-generation drug-susceptibility testing at microscopy centres
- Pathway Status: 2-DevelopmentPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
TB Breathalyser
Tuberculosis
Update Date: 20.06.17
- 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-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: No
- Funders:
- FIND Portfolio: Yes
- Remark:
Cobas MTB-RIF/INH
Tuberculosis
Update Date: 25.06.18
- Company Name: Roche
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 5-WHO evaluationObj: Evaluation or demonstration studies to inform WHO policy
Milestone: WHO endorsement / Pre-qualified products
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: For use with the COBAS 6800/8800 Systems
Mycolor TK platform
Tuberculosis
Update Date: 20.06.17
- Company Name: Salubris
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Platform
- Technology Type: Growth based
- Biomarker Type: Whole bug
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
TB Flow
Tuberculosis
Update Date: 12.03.18
- Company Name: Salus Discovery, LLC
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: A rapid biomarker-based non-sputum-based test for detecting TB
- Pathway Status: 1-ConceptPre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark: Urine based LFA test. Test includes a concentration step that aims to improve sensitivity.
Scanogen
Tuberculosis
Update Date: 20.06.17
- Company Name: Scanogen, Inc.
- Company Size: Small< 50 FTE | ≤ EUR 10 m
- Product Type: Dx Assay
- Technology Type: Other
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Next-generation drug-susceptibility testing at microscopy centres
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark:
Anyplex assays for MDR/XDR series
Tuberculosis
Update Date: 20.06.17
- Company Name: Seegene, Inc.
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
TB MultiTest
Tuberculosis
Update Date: 20.06.17
- 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-DevelopmentPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Aeonose for TB
Tuberculosis
Update Date: 20.06.17
- 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-ValidationPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark:
VersaTREK
Tuberculosis
Update Date: 20.06.17
- Company Name: Thermo Fisher
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: Growth based
- Biomarker Type: Whole bug
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS:
- Funders:
- FIND Portfolio:
- Remark:
Sensititre MYCOTB MIC plate
Tuberculosis
Update Date: 20.06.17
- Company Name: Thermo Fisher
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: Growth based
- Biomarker Type: Whole bug
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: CE-IVD-marked. For research use only in the U.S.
VereMTB Detection Kit
Tuberculosis
Update Date: 01.11.17
- 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-ValidationPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: RUO Product based on multiplex PCR and microarray technology.
MolecuTech REBA MDR/XDR assays series
Tuberculosis
Update Date: 20.06.17
- Company Name: YD Diagnostics
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (LPA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
MeltPro MTB (MDR-TB, XDR-TB) kits
Tuberculosis
Update Date: 20.06.17
- Company Name: Zeesan Biotech
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
LED Microscopy
Tuberculosis
Update Date: 25.06.18
- Company Name: Multiple
- Company Size: NA
- Product Type: Platform
- Technology Type: Microscopy
- Biomarker Type: Whole bug
- TPP: Rapid sputum-based test for detecting TB at the microscopy-centre level of the health-care system
- Pathway Status: 8-Scale-up & ImpactPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: E.g. Primo Star iLED (Zeiss)
Molecular Stool
Tuberculosis
Update Date: 05.10.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: NA
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Next-generation drug-susceptibility testing at microscopy centres
- Pathway Status: 2-DevelopmentPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: FIND, ELMA Fdn & Partners, Univ. Bordeaux, Others
NA-NOSE
Tuberculosis
Update Date: 02.10.17
- Company Name: Breathtec Biomedical, Inc.
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Spectroscopy
- Biomarker Type: Metabolite
- TPP: Community-based triage or referral test for identifying people suspected of having TB
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: In collaboration with the Israel Institute of Technology (ÛÏTechnionÛÏ).
MtB Drug Resistance DX
Tuberculosis
Update Date: 21.06.17
- Company Name: Omniome, Inc.
- Company Size: Small< 50 FTE | ≤ EUR 10 m
- Product Type: Dx Assay
- Technology Type: Sequencing
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Next-generation drug-susceptibility testing at microscopy centres
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: No
- Funders:
- FIND Portfolio: Yes
- Remark:
Blood host marker POC Tests
Tuberculosis
Update Date: 02.10.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: Community-based triage or referral test for identifying people suspected of having TB
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: SomaLogic, ScreenTB, Broad Inst., Others
MTB-antigens POC assays
Tuberculosis
Update Date: 30.01.18
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: A rapid biomarker-based non-sputum-based test for detecting TB
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: NanoTin & ASU, Tufts Univ., Others
Blood/urine cfDNA POC assays
Tuberculosis
Update Date: 02.10.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: A rapid biomarker-based non-sputum-based test for detecting TB
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: Stanford Univ., Cornell Univ., Karius, Alere/Clondiag, Others
High sensitivity TB rapid diagnostic
Tuberculosis
Update Date: 20.06.17
- Company Name: Global Good
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: A rapid biomarker-based non-sputum-based test for detecting TB
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark:
Mycobacterial culture & Rapid speciation
Tuberculosis
Update Date: 02.10.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: NA
- Biomarker Type: NA
- TPP: Centralized drug susceptibility testing (DST)
- Pathway Status: 8-Scale-up & ImpactPre-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 LaboratoryHospital staff | Large footprint & Complex Instruments
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: Tauns, BD, SD-Alere, others
Molecular Bacterial Load Assay (MBLA)
Tuberculosis
Update Date: 29.08.18
- 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-ConceptPre-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 LaboratoryHospital 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.
Malaria RDT
Malaria
Update Date: 15.08.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: PvA: P. vivax (acute)
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: See: UNITAID Malaria Diagnostics Technology and Market Landsape 3rd edition, WHO Product Testing and WHO PQ
Alere Malaria Ag P.f
Malaria
Update Date: 15.08.17
- Company Name: Alere/Standard Diagnostics
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: Pf: P. falciparum (subpatent)
- Pathway Status: 5-WHO evaluationObj: Evaluation or demonstration studies to inform WHO policy
Milestone: WHO endorsement / Pre-qualified products
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders: BMGF
- FIND Portfolio: Yes
- Remark: Highly sensitive lateral flow immunochromatographic antigen-detection tests
HS RDT
Malaria
Update Date: 15.08.17
- Company Name: AccessBio
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: Pf: P. falciparum (subpatent)
- Pathway Status: 2-DevelopmentPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders: Global Good
- FIND Portfolio: No
- Remark: Advanced lateral flow assay and reader system that detects nanoparticles tagged to key biomarkers of malaria.
Urine Malaria Test
Malaria
Update Date: 15.11.15
- Company Name: Fyodor Biotechnologies
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: PvA: P. vivax (acute)
- Pathway Status: 6-Country pre-launchPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders: US SBIR & others
- FIND Portfolio: No
- Remark: Lateral flow immunochromatographic antigen-detection test
Parasight
Malaria
Update Date: 15.11.16
- Company Name: Sight Diagnostics Ltd.
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Platform
- Technology Type: Microscopy
- Biomarker Type: Whole bug
- TPP: PvA: P. vivax (acute)
- Pathway Status: 6-Country pre-launchPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: Automated, computer assisted microscopy. Benchtop device using disposable cartridges; quantitative, high throughput (30 samples batched).
Parasight POC
Malaria
Update Date: 15.11.16
- Company Name: Sight Diagnostics Ltd.
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Platform
- Technology Type: Microscopy
- Biomarker Type: Whole bug
- TPP: PvA: P. vivax (acute)
- Pathway Status: 2-DevelopmentPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: Automated, POC computer assisted microscopy. Point of care device using disposable cartridges; quantitative, low throughput (processes one sample at a time)
Truelab micro PCR platform
Malaria
Update Date: 15.11.15
- Company Name: Molbio Diagnostics
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Platform
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: PvA: P. vivax (acute)
- Pathway Status: 3-ValidationPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Improved P. falciparum and P. vivax RDT
Malaria
Update Date: 17.05.19
- Company Name: Abbott
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: Other
- Pathway Status: 3-ValidationPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS:
- Funders: BMGF
- FIND Portfolio: Yes
- Remark:
Improved P. falciparum RDT
Malaria
Update Date: 17.05.19
- Company Name: Abbott
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: Other
- Pathway Status: 3-ValidationPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS:
- Funders: BMGF
- FIND Portfolio: Yes
- Remark:
NALFIA DIAGMAL
Malaria
Update Date: 15.11.15
- Company Name: DIAGMAL Consortium
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: PCR (LFA)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: PvB1/PvB2: P. vivax (subpatent)
- Pathway Status: 3-ValidationPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: No
- Funders: European Framework 7
- FIND Portfolio: No
- Remark: PCR: commercial kit uses disposable nucleic acid lateral flow immunoassay (NALFIA) for detection. Kit contains all necessary primers and reagents in stabilized form, as well as NALFIA lateral flow device to run test after amplification on traditional PCR thermocycler.
Q-POC system with malaria assay
Malaria
Update Date: 17.06.18
- Company Name: QuantuMDx
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Platform
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
- Pathway Status: 2-DevelopmentPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders: European Framework 7
- FIND Portfolio: No
- Remark: POC automated PCR. Hand-held, battery operated POC PCR device. Uses disposable cartridges that are pre-loaded with reagents and probes required to prep sample and run assay. Will include qualitative output for five malaria species; TBD drug resistance testing.
Accutas
Malaria
Update Date: 15.11.15
- Company Name: Aquila Diagnostics Systems
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Platform
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
- Pathway Status: 2-DevelopmentPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: POC automated PCR. Hydrogel-based POC PCR, using disposable plastic tubes of desiccated hydrogel reagents for malaria PCR.
Loopamp MALARIA Pan/Pf detection kit
Malaria
Update Date: 15.11.15
- Company Name: Eiken Chemical Co., Ltd
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
- Pathway Status: 6-Country pre-launchPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: P. vivax test in validation. LAMP: low throughput. Field stable quality assured LAMP kit for simplified, molecular detection using whole blood or dried blood spots. Qualitative results. 8 well format for individual testing.
High throughput LAMP sample processing kit
Malaria
Update Date: 15.11.15
- Company Name: Eiken Chemical Co., Ltd
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: PvB1/PvB2: P. vivax (subpatent)
- Pathway Status: 6-Country pre-launchPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: LAMP: high throughput. LAMP kit for simplified, high throughput malaria detection using whole blood or dried blood spots. Qualitative results. 96 well format for population screening. FIND, Porvair Sciences, 42 Technology, London Hospital for Tropical Diseases.
Illumigene Malaria
Malaria
Update Date: 15.11.15
- Company Name: Meridian Bioscience, Inc.
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: PvA: P. vivax (acute)
- Pathway Status: 6-Country pre-launchPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: LAMP: low throughput. Malaria LAMP assay for illumigene benchtop system, quality assured, simple molecular detection, qualitative results.
Rapid Assessment of Malaria (RAM)
Malaria
Update Date: 15.11.15
- Company Name: Disease Diagnostic Group, Inc.
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Dx Assay
- Technology Type: Spectroscopy
- Biomarker Type: Metabolite
- TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
- Pathway Status: 2-DevelopmentPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: POC Hemozoin detection. Portable (2 x 3 x 4 inches), rapid device using disposable plastic cuvettes.
Magneto-optical Device (MOD)
Malaria
Update Date: 15.11.15
- Company Name: Meditopian LLC and Case Western Reserve University
- Company Size: Pre-CompanyNo 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-ValidationPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark: POC Hemozoin detection. Portable, rapid device using a reader and disposable cuvette.
Transdermal detection of nanobubbles.
Malaria
Update Date: 15.11.15
- Company Name: Rice University, Masimo
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Spectroscopy
- Biomarker Type: Metabolite
- TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
- Pathway Status: 2-DevelopmentPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: Transdermal Hemozoin detection. Device-based, transdermal detection of hemozoin on reagentless system.
Hemozoin detection device.
Malaria
Update Date: 15.11.15
- Company Name: Budapest University of Technology and Economics
- Company Size: Pre-CompanyNo 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-ConceptPre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: Hemozoin detection device. High-sensitivity diagnosis of malaria via magnetically induced linear dichroism.
Autoscope
Malaria
Update Date: 15.11.15
- Company Name: Global Good Fund at Intellectual Ventures
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx Assay
- Technology Type: Microscopy
- Biomarker Type: Whole bug
- TPP: PvA: P. vivax (acute)
- Pathway Status: 3-ValidationPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: NA
- Funders: Global Good
- FIND Portfolio: No
- Remark: Automated computer assisted microscopy. Reads Giemsa-stained blood samples. Speciates, quantitative results.
xRapid-Malaria
Malaria
Update Date: 15.11.15
- Company Name: xRapid
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Adjunct tool
- Technology Type: Microscopy
- Biomarker Type: Whole bug
- TPP: PvA: P. vivax (acute)
- Pathway Status: 2-DevelopmentPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: Cell phone based microscopy.
NA
Malaria
Update Date: 15.11.15
- Company Name: Indian Institute of Science
- Company Size: Pre-CompanyNo legal entity
- Product Type: Dx Assay
- Technology Type: Microscopy
- Biomarker Type: Whole bug
- TPP: PvA: P. vivax (acute)
- Pathway Status: 1-ConceptPre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: Microfluidic cartridge processes samples, optical reader and image processing software.
Attenuated total reflection-fourier transform infrared spectroscopy
Malaria
Update Date: 15.11.15
- Company Name: Monash University, University of Melbourne
- Company Size: Pre-CompanyNo legal entity
- Product Type: Dx Assay
- Technology Type: Spectroscopy
- Biomarker Type: Whole bug
- TPP: PvA: P. vivax (acute)
- Pathway Status: 1-ConceptPre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org - Lowest Health Level: NA
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: POC spectroscopy device. Portable device based on attenuated total reflection-fourier transform infrared spectroscopy. Pilot study in Thailand.
ID-FISH Plasmodium Genus Test Kit; ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
Malaria
Update Date: 15.06.14
- Company Name: ID-FISH Technology Inc.
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Adjunct tool
- Technology Type: Microscopy
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: PvA and/or PvB1/PvB2: P. vivax (acute and/or subpatent)
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L1-Microscopy CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: Fluorescent probes that bind with parasite RNA causing malaria-infected cells to fluoresce when viewed under a fluorescent microscope.
Malaria serology ELISA
Malaria
Update Date: 15.02.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody+Antigen
- TPP: PvB1/PvB2: P. vivax (subpatent)
- Pathway Status: 7-Country adoptionMilestone: Diagnostic algorithm or Country policy change
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: ELISA tests that detect antibodies associated with Plasmodium infection
Malaria serology RDT
Malaria
Update Date: 15.02.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody+Antigen
- TPP: PvB1/PvB2: P. vivax (subpatent)
- Pathway Status: 7-Country adoptionMilestone: Diagnostic algorithm or Country policy change
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: Lateral flow immuno-chromatographic antibody-detection tests
Sero-surveillance for Pv.
Malaria
Update Date: 15.05.17
- Company Name: Walter and Eliza Hall Institute, Institute Pasteur, FIND
- Company Size: Pre-CompanyNo legal entity
- Product Type: Adjunct tool
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: PvB1/PvB2: P. vivax (subpatent)
- Pathway Status: 1-ConceptPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: NA
- Funders: GHIT
- FIND Portfolio: Yes
- Remark: Serology: high throughput. High throughput, multiplex ELISA or other platform that detects antibodies marking recent Pv infection, for use in surveillance.
Sero-test and treat for Pv.
Malaria
Update Date: 15.05.17
- Company Name: Walter and Eliza Hall Institute, Institute Pasteur, FIND
- Company Size: Pre-CompanyNo legal entity
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: PvB1/PvB2: P. vivax (subpatent)
- Pathway Status: 1-ConceptPre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders: GHIT
- FIND Portfolio: Yes
- Remark: POC Serology. POC test that detects antibodies indicating recent exposure (about 9 months) to Pv, used to inform radical cure treatment.
Serology RDT
Malaria
Update Date: 15.05.17
- Company Name: Consortium
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Adjunct tool
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: PvB1/PvB2: P. vivax (subpatent)
- Pathway Status: 2-DevelopmentPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders: Global Good
- FIND Portfolio: No
- Remark: Advanced lateral flow assay and reader system that detects nanoparticles tagged to key serological biomarkers of malaria.
Serology RDT
Malaria
Update Date: 15.05.17
- Company Name: Burnet Institute; Nanjing Bio Point
- Company Size: NA
- Product Type: Adjunct tool
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: PvB1/PvB2: P. vivax (subpatent)
- Pathway Status: 2-DevelopmentPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: Lateral flow immuno-chromatographic antibody-detection tests; quantitative output.
Serology assay for recent exposure in pregnant women.
Malaria
Update Date: 15.05.17
- Company Name: IS Global
- Company Size: Pre-CompanyNo legal entity
- Product Type: Adjunct tool
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Other
- Pathway Status: 1-ConceptPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: A surveillance tool detecting antibodies against VAR2CSA.
Battery/solar powered simple imaging cytometer.
Malaria
Update Date: 15.11.15
- Company Name: One world Cytometry Inc.
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Platform
- Technology Type: Immunoassay
- Biomarker Type: Metabolite
- TPP: Other
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark:
miLab Malaria
Malaria
Update Date: 22.12.17
- 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-ValidationPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: No
- Funders: KOICA
- FIND Portfolio: No
- Remark: Automated POC microscopy platform integrating innovative Tubing-Free Lab on a Chip, mobile imaging platform, and artificial intelligence for image analysis.
Pinpoint Malaria Meter
Malaria
Update Date: 26.04.18
- 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-ConceptPre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark: IVD solution that will provide detection of malaria (HRP2) in seconds using either saliva or fingerprick blood sample using a low-cost reader, disposable cartridges, and a mobile app, allowing data to be captured in a cloud repository. The product is based on a novel nanosensor technology developed by University of California/Santa Cruz.
ImmunoPOC
Fever
Update Date: 27.10.2017
- Company Name: Memed Diagnostics
- Company Size: Small< 50 FTE | ≤ EUR 10 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: Bacterial versus non-bacterial differentiation test for fever
- Pathway Status: 2-DevelopmentPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: ImmunoPoC relies on measurements of the immune response to diagnose the source of infection.
HNL test
Fever
Update Date: 27.10.2017
- Company Name: Diagnostics Development/Ag Plus Diagnostics
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: Bacterial versus non-bacterial differentiation test for fever
- Pathway Status: 2-DevelopmentPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: Measurement of HNL in whole blood after few minutes of activation
FebriDx
Fever
Update Date: 27.10.2017
- Company Name: RPS Diagnostics
- Company Size: Small< 50 FTE | ≤ EUR 10 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: Bacterial versus non-bacterial differentiation test for fever
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark:
Malaria/CRP duo test
Fever
Update Date: 27.10.2017
- Company Name: SD Biosensor
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: Bacterial versus non-bacterial differentiation test for fever
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: This is a a combo test for Malaria and non-Malaria fever
Landscape CRP Tests
Fever
Update Date: 07.09.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: Bacterial versus non-bacterial differentiation test for fever
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: Landscape of CRP tests coordinated by FIND.
Landscape PCT Tests
Fever
Update Date: 07.09.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx Assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: Bacterial versus non-bacterial differentiation test for fever
- Pathway Status: 4-Regulatory achievedPre-requisite: CE-IVD, FDA, CFDA or similar regulatory approval in domestic country
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: Landscape of PCT tests coordinated by FIND.
Predigen B/V
Fever
Update Date: 04.04.19
- Company Name: Predigen
- Company Size:
- 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-ConceptPre-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/HospitalLab 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.
HostDx Fever
Fever
Update Date: 08.03.18
- Company Name: Inflammatix, Inc.
- Company Size: Small< 50 FTE | ≤ EUR 10 m
- Product Type: Dx Assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Bacterial versus non-bacterial differentiation test for fever
- Pathway Status: 1-ConceptPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: A molecular technology measuring the expression levels of numerous host immune genes, and then applying proprietary algorithms to produce rapid, clinically actionable results.
ASPIRE
Malaria
Update Date: 22.03.18
- Company Name: VisionQuest Biomedical LLC
- Company Size: Small< 50 FTE | ≤ EUR 10 m
- Product Type: Dx Assay
- Technology Type: Imaging
- Biomarker Type: Other
- TPP: Other
- Pathway Status: 1-ConceptPre-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/HospitalLab technician | RDT, molecular tests, ELISA C7
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark: A malarial retinopathy detection system consisting of an automatic malarial retinopathy detection software integrated with low-cost and portable retinal camera designed for use in clinical settings. The ASPIRE system aims to augment the current cerebral malaria diagnostic standard.
SD BIOLINE HAT
HAT
Update Date: 09.02.18
- Company Name: Standard Diagnostics/Abbott
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Screening
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders: Multiple
- FIND Portfolio: Yes
- Remark: Screening test including 2 native antigens
HAT Sero K-SeT
HAT
Update Date: 09.02.18
- Company Name: Coris BioConcept
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Screening
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
SD BIOLINE HAT 2.0
HAT
Update Date: 09.02.18
- Company Name: Standard Diagnostics/Abbott
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Screening
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders: Multiple
- FIND Portfolio: Yes
- Remark: Screening test including 2 recombinant antigens
Loopamp Trypanosoma brucei Detection Kit
HAT
Update Date: 09.02.18
- Company Name: Eiken Chemical Co., Ltd
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Screening
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: Yes
- Funders: Multiple
- FIND Portfolio: Yes
- Remark:
SD BIOLINE HAT/Malaria Duo
HAT
Update Date: 09.02.18
- Company Name: Standard Diagnostics/Abbott
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody+Antigen
- TPP: Screening/Diagnosis
- Pathway Status: 3-ValidationPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders: Multiple
- FIND Portfolio: Yes
- Remark: For simultaneous screening for g-HAT and diagnosis of P. falciparum malaria
2nd generation RDT (name to be confirmed)
HAT
Update Date: 24.02.18
- Company Name: Coris BioConcept
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Screening
- Pathway Status: 3-ValidationPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
iELISA (immune trypanolysis)
HAT
Update Date: 24.02.18
- Company Name: Institute of Tropical Medicine, Antwerp
- Company Size: Research Institute
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Other
- TPP: Screening
- Pathway Status: 2-DevelopmentPre-requisite: Dev. under QMS / Analytical data available
Obj: Assay optimization / Manufacturability assessment
Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference Lab
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Loopamp Trypanosoma cruzi Detection Kit
Chagas
Update Date: 17.08.17
- Company Name: Eiken Chemical Co., Ltd
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Congenital (acute) Chagas disease
- Pathway Status: 3-ValidationPre-requisite: Design locked product or near / Pilot line for manufacturing
Obj: Laboratory/clinical validation
Milestone: Statistically powered studies on patient samples / Manufacturing in place
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: Yes
- Funders:
- FIND Portfolio: Yes
- Remark: LAMP test developed by FIND, EIKEN and other partners
LAMP Chagas (not defined)
Chagas
Update Date: 20.02.18
- Company Name: Multiple
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Congenital (acute) Chagas disease
- Pathway Status: 3-ValidationPre-requisite: Design locked product or near / Pilot line for manufacturing
Obj: Laboratory/clinical validation
Milestone: Statistically powered studies on patient samples / Manufacturing in place
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: NA
- Funders: Ministerio de Ciencia, Tecnología, e Innovación Productiva
- FIND Portfolio: No
- Remark: LAMP test develped by a Consortium: CONICET - UNIFARMA S. A. - LABORATORIO PABLO CASSARÁ S. A
CHUNAP (not defined)
Chagas
Update Date: 17.08.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: Congenital (acute) Chagas disease
- Pathway Status: 2-DevelopmentPre-requisite: Dev. under QMS / Analytical data available
Obj: Assay optimization / Manufacturability assessment
Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: NA
- Funders: National Institute of Health
- FIND Portfolio: No
- Remark: Antigen detection test developed by the University of California and other academic groups.
SAPA (not defined)
Chagas
Update Date: 19.02.18
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: Congenital (acute) Chagas disease
- Pathway Status: 2-DevelopmentPre-requisite: Dev. under QMS / Analytical data available
Obj: Assay optimization / Manufacturability assessment
Milestone: Design locked product or near / Patient samples measured / Pilot manufacturing
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: ELISA to detect T. cruzi Shed Acute Phase Antigen (SAPA) developed by the Instituto Nacional de Parasitología (INP) Dr. M. Fatala Chaben and other academic groups
InfYnity Chagas ToC (not defined)
Chagas
Update Date: 22.08.17
- Company Name: InfYnity Biomarkers
- Company Size: Micro< 10 FTE | ≤ EUR 2 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Test of cure
- Pathway Status: 1-ConceptPre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: No
- Funders:
- FIND Portfolio: No
- Remark: ELISA & Multiplex developped for diagnosis and treatment monitoring
NA
Chagas
Update Date: 22.08.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Other
- TPP: Test of cure
- Pathway Status: 1-ConceptPre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark: Several academic groups are working on biomarkers to be used to monitor treatment efficacy
f-TLC
Buruli ulcer
Update Date: 28.08.17
- Company Name: Harvard University
- Company Size: Research Institute
- Product Type: Dx assay
- Technology Type: Other
- Biomarker Type: Other
- TPP: Diagnosis
- Pathway Status: 3-ValidationPre-requisite: Design locked product or near / Pilot line for manufacturing
Obj: Laboratory/clinical validation
Milestone: Statistically powered studies on patient samples / Manufacturing in place
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: No
- Funders: FIND and others
- FIND Portfolio: Yes
- Remark: The target is mycolactone, a toxin. Polyketide-derived macrolide. f-TLC is a home brewed method developed by Harvard University that WHO has adopted for evaluation and implementation at diszrict hospital level in seleceted sites, while other tests are developed.
BUD-LAMP (not defined)
Buruli ulcer
Update Date: 28.08.17
- Company Name: DITM/KUM, NMIMR, Optigene
- Company Size: Research Institute
- Product Type: Dx assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Diagnosis
- Pathway Status: 2-DevelopmentPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders: UBS-Optimus Foundation, Anesvad
- FIND Portfolio: Yes
- Remark:
BU-RDT (not defined)
Buruli ulcer
Update Date: 28.08.17
- Company Name: Standard Diagnostics/Abbott
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Protein
- TPP: Diagnosis
- Pathway Status: 2-DevelopmentPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders: UBS-Optimus Foundation, Anesvad, Swiss Agency for Development and Cooperation, German Federal Ministry of Education and Research
- FIND Portfolio: Yes
- Remark:
BU ELONA (not defined)
Buruli ulcer
Update Date: 08.09.17
- Company Name: Aptagen LLC
- Company Size: Small< 50 FTE | ≤ EUR 10 m
- Product Type: Dx assay
- Technology Type: Other
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Diagnosis
- Pathway Status: 1-ConceptPre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: No
- Funders: BMGF
- FIND Portfolio: No
- Remark: Other academic partners are also involved.
Loopamp Leishmania Detection Kit
Leishmaniasis
Update Date: 28.08.17
- Company Name: Eiken Chemical Co., Ltd
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Diagnosis
- Pathway Status: 3-ValidationPre-requisite: Design locked product or near / Pilot line for manufacturing
Obj: Laboratory/clinical validation
Milestone: Statistically powered studies on patient samples / Manufacturing in place
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: Yes
- Funders: German Federal Ministry of Education and Research
- FIND Portfolio: Yes
- Remark:
Leishmaniasis-RDT (not defined)
Leishmaniasis
Update Date: 28.08.17
- Company Name: Multiple
- Company Size: NA
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antigen
- TPP: Diagnosis
- Pathway Status: 1-ConceptPre-requisite: Needs assessed / PRD available
Obj: Show probability of success
Milestone: Prototype but not design lock
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: NA
- Funders: Swiss Agency for Development and Cooperation
- FIND Portfolio: Yes
- Remark: This a very early stage project, with a panel of mAbs identified for characterization. Best mAb pairs for prototype RDT development have not been selected yet. This test is envisioned to have an additional application for a test of cure.
Leismaniasis IgG1-RDT (not defined)
Leishmaniasis
Update Date: 28.08.17
- Company Name: Coris BioConCept
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Test of cure
- Pathway Status: 2-DevelopmentPre-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-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders: European Commission
- FIND Portfolio: No
- Remark: LSHTM is also involved in the project.
LD RPA (not defined)
Leishmaniasis
Update Date: 28.08.17
- Company Name: TwistDx
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Diagnosis
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders: WHO/TDR
- FIND Portfolio: No
- Remark: Other research institutes are also involved.
RPA-LF (not defined)
Leishmaniasis
Update Date: 28.08.17
- Company Name: TwistDx
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx assay
- Technology Type: PCR (Isothermal)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Diagnosis
- Pathway Status: 1-ConceptPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: NA
- Funders: AFHSC/GEIS (US)
- FIND Portfolio: No
- Remark: Other research institutes are also involved.
CL Detect Rapid Test for Cutaneous Leishmaniasis
Leishmaniasis
Update Date: 08.09.17
- Company Name: InBios International
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antigen
- TPP: Diagnosis
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Leishmania OligoC-TesT
Leishmaniasis
Update Date: 18.03.18
- Company Name: Coris BioConcept
- Company Size: Medium< 250 FTE | ≤ EUR 50 m
- Product Type: Dx assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Diagnosis
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L3-Reference Lab
- Certified QMS: NA
- Funders:
- FIND Portfolio: No
- Remark:
SD BIOLINE Leishmania Ab
Leishmaniasis
Update Date: 18.03.18
- Company Name: Standard Diagnostics/Abbott
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Diagnosis
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
IT-Leish
Leishmaniasis
Update Date: 18.03.18
- Company Name: BIO-RAD
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Diagnosis
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Kalazar Detect
Leishmaniasis
Update Date: 18.03.18
- Company Name: InBios International
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Diagnosis
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Leishmania IgG/IgM Combo Rapid Test CE
Leishmaniasis
Update Date: 18.03.18
- Company Name: CTK Biotech
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Diagnosis
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Leishmania Ab Rapid Test CE
Leishmaniasis
Update Date: 18.03.18
- Company Name: CTK Biotech
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Diagnosis
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Leishmania Ab ELISA Test CE
Leishmaniasis
Update Date: 18.03.18
- Company Name: CTK Biotech
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antibody
- TPP: Diagnosis
- Pathway Status: 8-Scale-up & ImpactPre-requisite: Diagnostic algorithm or Country policy change
Milestone: 1 peer-reviewed cost-effectivenees or impact study
URL: www.tbdxpathway.org - Lowest Health Level: L0-CommunityMinimally trained health worker | RDT
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
Katex
Leishmaniasis
Update Date: 18.03.18
- Company Name: Kalon Biological Ltd.
- Company Size: Small< 50 FTE | ≤ EUR 10 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: Diagnosis
- Pathway Status: 8-Scale-up & ImpactPre-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 CenterClinic staff | RDT, handheld instruments, battery operated C4
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark: The antigen is a carbohydrate.
VL ELISA
Leishmaniasis
Update Date: 18.03.18
- Company Name: Kalon Biological Ltd.
- Company Size: Small< 50 FTE | ≤ EUR 10 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: Diagnosis
- Pathway Status: 3-ValidationPre-requisite: Design locked product or near / Pilot line for manufacturing
Obj: Laboratory/clinical validation
Milestone: Statistically powered studies on patient samples / Manufacturing in place
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: NA
- Funders:
- FIND Portfolio: Yes
- Remark: The antigen is a carbohydrate.
Leishmania Antigen Detect ELISA
Leishmaniasis
Update Date: 21.03.18
- Company Name: InBios International
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: Immunoassay
- Biomarker Type: Antigens
- TPP: Diagnosis
- Pathway Status: 3-ValidationPre-requisite: Design locked product or near / Pilot line for manufacturing
Obj: Laboratory/clinical validation
Milestone: Statistically powered studies on patient samples / Manufacturing in place
URL: www.tbdxpathway.org - Lowest Health Level: L2-District Lab
- Certified QMS: Yes
- Funders:
- FIND Portfolio: No
- Remark:
STAT-NAT Leishmania
Leishmaniasis
Update Date: 18.03.18
- Company Name: Sentinel Diagnostics
- Company Size: Large≥250 FTE | > EUR 50 m
- Product Type: Dx assay
- Technology Type: PCR (Conventional)
- Biomarker Type: Nucleic Acid (RNA, DNA)
- TPP: Diagnosis
- Pathway Status: 8-Scale-up & ImpactPre-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:
Version: beta-version
The tracker is an interactive diagnostics pipeline that maps the status and estimated release dates of different diagnostic tests and offers a bird’s eye view of the diagnostic landscape, including a timeline for when products will become available for implementation. The Status View shows each technology along the stages of development. The Timeline View illustrates the approximate date of commercial availability, in low- and middle-income countries, for each product based on data that is publicly available. In the future, all diseases in FIND’s portfolio will be included in the interface.
To update information on the pipeline tracker, or to add a new product, kindly fill out this form.
DISCLAIMER: The Information used in this Pipeline was supplied directly from the companies or found in the public domain associated with the specific products, and should be considered “as is” (“Information”). Under no circumstances shall FIND be responsible or warrant for the accuracy of any of the Information used in the Pipeline. FIND shall not be responsible and will not indemnify any third party in any way, for loss, claim, damage, or liability, of whatsoever kind or nature, which may arise from or in connection with the use of the Information. Use of any such Information, for whatever purpose, shall be at the users own risk and liability. Images, status and time estimates are to be taken as indicative. The timeline uses latest best estimates for when technologies are expected to receive WHO recommendation. However, not all of the products in earlier stages are expected to receive WHO recommendation and therefore the timelines are only estimates. FIND encourages product developers to provide updates relevant to their products using the “Submit/Update a product” functionality above to ensure the most up-to-date Information is always provided.
x