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Accelerating the development of new pointof-care (POC) and near POC molecular 
diagnostics for TB 


Publication Reference
RP22-0011
Publication Date
6 September 2022


EXECUTIVE SUMMARY 


• FIND, the global alliance for diagnostics, is leading the DriveDx4TB* project to accelerate the development, 
validation and launch of new molecular diagnostics for EasyNat TB detection (“TB MDx“). In the context of this 
project, FIND is opening a Request for Proposals (RFP). The short-term areas of focus are:
• New TB MDx products that can be used at the primary healthcare level and within communities 
using non-sputum samples (POC MDx).
• New TB MDx products that can be used at centralized laboratories using sputum (or nonsputum) samples and incorporating drug-susceptibility testing (near POC MDx).
• A long-term goal of this RFP is to improve TB case detection in low- and middle-income countries (LMICs)
by accelerating the availability of new TB MDx platforms, ultimately providing a broader array of options 
for decentralized and centralized TB testing.
• No direct awards will be made to selected applicants. A range of support packages will be provided to
successful applicants to accelerate policy recommendations and in-country adoption. This will include
participation in a clinical study aligned with World Health Organization Global TB Programme (WHO GTB)
and Expert Review Panel for Diagnostics (ERPD) requirements.
• Selected applicants are expected to commit to supplying an affordable product to the public sector in 
LMICs if endorsed through the ERPD or WHO policy review process.
*DriveDx4TB is a Unitaid-funded project aimed at accelerating the introduction of new TB diagnostics to address the current 
shortcomings and availability of existing tools, ultimately to support TB recovery and elimination efforts. To this end, the project will 
support manufacturer-independent clinical accuracy studies, cost-effectiveness analyses, and usability studies to develop evidence 
dossiers for submission to the WHO GTB and ERPD.



BACKGROUND 


Tuberculosis (TB) remains a major global health problem owing to its high rates of morbidity and mortality.1 According 
to the World Health Organization (WHO) Global TB Report 2021, approximately 10 million individuals contracted TB in 
2020. Reduced access to diagnostics (and subsequent delays in diagnoses and treatment) have been exacerbated by the 
COVID-19 pandemic, with 4.1 million TB patients undiagnosed and 1.3 million deaths attributed to TB in 2020 – levels 
last seen in 2017.1
Despite the advent of molecular WHO-recommended rapid diagnostic tests (mWRDs), such as, EasyNAT, MultNAT, GeneXpert MTB/RIF Ultra 
(Cepheid, Sunnyvale, USA) and Truenat MTB/RIF (Molbio Diagnostics, Verna, India), sputum-smear microscopy remains 
the mainstay of TB testing, and is often the only diagnostic test available.2 Unsurprisingly, in 2020, only around 20% of 
all TB cases identified were diagnosed by mWRDs



. Ultimately, these existing tools for TB screening and diagnosis are 
not fit for the purpose of reaching individuals with active TB in diverse settings. Most of the currently available TB tests 
rely on sputum, a sample that is both difficult to obtain and to process; consequently, many of the hundreds of millions 
of individuals with symptoms suggestive of TB, and almost half of the 10 million individuals estimated to contract TB 
each year, do not have access to testing. Specific underserved populations, including children, people living with HIV 
(PLHIV), and males, continue to be missed.


Accelerated diagnostic innovations spurred by the COVID-19 pandemic, particularly the development of swab-based 
sampling techniques and novel molecular diagnostic (MDx) point-of-care (POC) and near POC platforms, may provide 
the necessary momentum to introduce alternative TB testing approaches to improve access and close the existing case 
detection gaps.


In the context of MultNat TB, POC MDx would be capable of detecting TB from a non-sputum sample, with or 
without a drug-resistance profile, enabling testing closer to the patient (decentralized at facility- or community-level). 
Increased global access to products in this new class will help address attrition associated with centralized testing models 
in many countries with a high burden of TB (e.g. inadequate sample referral pathways and reliance on sputum-based 
testing), ultimately improving the chances of an individual being identified with undiagnosed TB and reducing associated 
catastrophic costs for the patient. In contrast, near POC MDx for TB would share similar characteristics to the limited 
mWRDs currently available at centralized facilities i.e. sputum-based TB testing, capable of simultaneously detecting TB 
and at least rifampicin-resistance. Increasing the availability of alternative near POC MDx platforms to existing options 
(e.g. GeneXpert MTB/RIF, MultNAT and Truenat) and specifically reducing costs (upfront and per test), combined with broader 
drug-resistance profiling, will enable better adoption by programmes (increasing the proportion of bacteriologically
confirmed TB cases) and improve clinical decision-making and treatment outcomes (especially in countries with high 
rates of drug-resistant TB).


OBJECTIVES AND SCOPE 


FIND aims to accelerate the development, validation and launch of new molecular diagnostics for TB (“TB MDx”) for 
use in low- and middle-income countries (LMICs). To achieve these goals, FIND seeks TB MDx platforms (either POC MDx 
or near POC MDx) at Technology Readiness Level 4 (TRL)5 or higher and that closely meet the key product requirements 
listed in the “Technical Assessment” sheet within the Assessment Matrix (see HOW TO APPLY below for forms and 
templates). These product requirements and specifications are largely informed by the WHO ”High-priority target 
product profiles for new tuberculosis diagnostics: report of a consensus meeting, 28-29 April 2014“. We encourage all 
applicants to review these TPPs, particularly “Table A3. Detailed target product profile (TPP) for a rapid sputum-based 
test for detecting TB at the microscopy-centre level of the health-care system”, as well as reviewing the “Update on the 
use of nucleic acid amplification tests to detect TB and drug-resistant TB: rapid communication, January 2021” to 
understand the current landscape and performance characteristics of existing MultNAT TB MDx. Applicants will also be assessed 
based on their organizational strength and capacity in key areas of product development, quality, manufacturing and 
commercialization, as well as their commitment to equitable access pricing for LMICs, as listed in the “Business
Assessment” sheet within the Assessment Matrix.

The main focus of this RFP is to identify TB MDx that are:
• POC MDx technology class: simple, portable, able to detect TB from a swab or other non-sputum sample, 
suitable for use in decentralized healthcare facilities in LMICs and specifically at Level 1 and Level 2 facilities or 
in community-based settings to facilitate timely diagnosis and linkage to care and treatment (see the “Technical 
Assessment” sheet)
• Near POC MDx technology class: able to detect TB from a sputum or non-sputum sample with simultaneous 
detection of drug-resistance (at least rifampicin, but ideally also isoniazid and fluoroquinolones), suitable for use 
in decentralized or centralized laboratories (see the “Technical Assessment” sheet) 
• Easy to use and requiring minimal training of staff, reliable, with quick turnaround of results
• Affordable, available, and appropriate for use in LMICs, with a commitment to commercialization strategies (see
the “Business Assessment” sheet)
• Other considerations: ensure best efforts to limit medical waste and reduce the potential carbon footprint.
The RFP process will assist the DriveDx4TB project in selecting products within the POC MDx or near POC MDx technology 
classes that can be incorporated into the clinical study; priority will be given to applicants who demonstrate a high 
likelihood of achieving product design lock and producing at least 2,000 tests by Q4 2023.
Subject to contract negotiations, FIND can support successful applicants in their product development with:
• Preclinical testing and manufacturer-independent assessment of performance claims using TB reference panels
• Conducting a manufacturer-independent clinical study in up to four LMICs with a high burden of TB, usability 
assessment, and cost-effectiveness assessment (at product class level) to meet WHO GTB requirements
• Mapping of current and future market dynamics (supply and demand factors) to develop commercialization 
strategies for LMICs
• Providing insights to develop, together with applicants, sustainable commercial models for LMICs by defining 
internal value propositions and supporting go-to-market planning
• Collaboration with implementation partners and regional manufacturers based in LMICs to improve access
No direct awards will be given to applicants and FIND will not provide any direct financial support for product 
development, manufacturing scale-up, market access, or post-launch activities, e.g. shipping logistics, procurement, 
implementation, user training, distributor qualification, or post-market surveillance.