Information for Manufacturers

• Independent, free-of-charge evaluation in state-of-the-art clinical trials at field sites (Peru and Moldova) for feasibility and assessment studies

• Rapid performance feedback on technologies and guidance on their optimal use in endemic settings

   

   

• Laboratory-based evaluation of assays using banked samples prior to clinical studies to determine whether prototype modifications are needed to improve functionality or accuracy

   

• Expert support from FEND-TB to develop tailored, fit-for-purpose product development plans that accelerate evidence generation for policy and regulatory review

• Non-sputum-based diagnostics and/or sampling strategies for detecting M. tuberculosis bacterial and host targets
• Diagnostics developed for specific subgroups (e.g., HIV-infected individuals)
• Sputum- and non-sputum-based diagnostics designed for point-of-care (POC) use
• Diagnostics that enable rapid drug susceptibility testing at or near the POC

FEND-TB studies will cover multibacillary and paucibacillary TB, pulmonary (PTB) and extra-pulmonary TB (EPTB), drug-susceptible and drug-resistant PTB, both sexes and all age groups, HIV-positive and HIV-negative individuals, and key comorbidities including diabetes mellitus.

Expressions of Interest (EOIs) can be submitted on this website at this link → Submission Form. 

Following submission, technologies will be reviewed by the FEND-TB Evaluation Committee. Selected technologies will be invited to participate in the joint development of a tailored project plan.

FEND-TB reviews submissions on a quarterly basis, and early submission is encouraged to support planning. Manufacturers can expect to receive feedback within four weeks of the closure of the current call for proposals.

There are three possible outcomes from the technology review:

1. Submission accepted: Manufacturers are invited to draft the collaboration agreement and define the evaluation protocols.
2. Submission not accepted: Manufacturers are directed to alternative programs to support the development of their technology. Future applications to FEND are not precluded.
3. Follow-up required: Additional information is requested before acceptance can be confirmed. Manufacturers must provide the requested details to the technology review committee.

The list below summarizes the most common reasons why a technology may not be accepted into the program:

• The proposed technology is at an early stage of development, and field evaluation is not yet warranted. Manufacturers are encouraged to reapply once the technology is ready for field testing.
• The proposed technology is at a late stage of development such that large-scale studies, beyond the scope of FEND-TB, are more appropriate.
• The proposed technology shows a low likelihood of implementation as a near-care or point-of-care test.
• Insufficient information was provided for the Technology Selection Team to accept the technology into the FEND-TB program.
• The technology submitted is not intended for TB diagnostics.
• The proposed technology cannot be evaluated within the approved protocols of FEND-TB.

Accepted technologies are typically evaluated through a phase-gated approach:

• Diagnostics are first assessed in a laboratory setting to ensure they meet minimum performance requirements.
• If laboratory criteria are met, technologies advance to field testing in the Adult and/or Drug Resistance protocol.
• Clinical evaluation is conducted in 2–3 stages: the first involves a small set of clinical samples; if performance criteria are met, the diagnostic is further evaluated in 1–2 larger studies with expanded sample sizes and more stringent criteria. Additional FEND sites or protocols are typically included following successful completion of stage 1.
• Manufacturers receive a progress report at the end of each phase.
• Technologies that do not meet criteria to advance will not continue in the evaluation process.
• Future applications to FEND are not precluded, provided that identified improvements have been addressed.

FEND evaluations are provided free of charge to manufacturers. Manufacturers are expected to:

• Supply the diagnostic test in sufficient quantity to cover the planned evaluation protocol.
• Cover costs associated with shipping the material, training users, and returning materials (if required) at the end of the evaluation.
• Provide insurance for loaned instrumentation, if applicable.