Call For Proposal

Effective diagnostics are the cornerstone of TB disease management. Expanding access to highly accurate testing, particularly in closer proximity to patients, is critical to ending the TB epidemic.

Addressing these barriers requires innovative decentralized point-of-care (PoC) rapid molecular diagnostics and tests that can be performed in community settings. Additionally supporting technologies that streamline sample processing (collection, lysis and preparation) in low-resource environments is also essential.

Due to its distinctive cell wall structure and resistance to traditional chemical lysis methods, Mycobacterium tuberculosis (MTB) typically requires instrumented mechanical lysis to achieve high sensitivity in molecular diagnostic assays (https://academic.oup.com/cid/article/78/5/1313/7596605). Therefore, developing adjunct technologies for sample collection, lysis, and preparation is crucial. Pre-analytical solutions, such as simplified sample collection and stabilization, and instrument free sample lysis specifically for TB could enable more reliable and consistent results while reducing reliance on complex laboratory infrastructure. Investing in these supportive

The specific objectives of this challenge will be to address one or all of the following

1.Test involving new sampling methods

• It is important to move away from sputum and towards more accessible.
• Easier to collect samples for TB diagnosis. It is also important to assess the suitability of other sample types, such as saliva or blood for TB testing.

2.Self-Sample Blood Collection Devices (Phlebotomist-free blood collection)

3.Sample Collection for MTB

4.Sample Lysis Devices (Instrument-free lysis) for TB lysis

5.Sample Clean up and Analyte Concentration

6.New testing technologies

Ideally, the proposal will:

• Solicit variety of upstream testing solutions that make sample collection, preparation, and lysis simpler, less expensive, and self-administered PoC or near- to-care tests;

• Diagnostics for underserved populations, such as children and individuals with disseminated and/or paucibacillary TB;
• Product candidates that detect TB using specimens other than sputum (blood, serum, urine, stool, breath, swabs), enabling the identification of extrapulmonary or paucibacillary TB in adult and pediatric patients
• Solutions or diagnostics that may be able to overcome the infrastructure and cost- related drawbacks of current diagnostic techniques
• The assessment of new TB diagnostic approaches in the context of current clinical algorithms in TB-endemic nations are also noteworthy.
• Brief laboratory tests on a diagnostic prototype or prototypes to verify functionality

and viability prior to a clinical review.

• Place a strong emphasis on systematically observing, validating, and quantifying the improved outcomes balanced with cost-effectiveness from its use.

This RFP is India-led; the programme is open to nonprofit organizations (society, trust and foundation), for-profit companies (start-ups), government agencies, individuals, and academic and research institutions.

Please visit the BIRAC website at www.birac.nic.in and follow the link to the registration and submission portal. If you are applying to a BIRAC/GCI scheme for the first time, please note that you will have to register on the portal. The verification and activation of your new account may take up to 24 hours before you can apply for the scheme. Please take this into account while applying.

Proposals in the correct format will be submitted on the online portal by interested applicants.

The online form needs to be filled completely with all appropriate documents uploaded.

Please also ensure that the Proposal Summary document is uploaded based on the format provided. Incomplete proposals will be rejected in the triage round

Announcement Date: 03-03-2025
Last Submission Date: 15-05-2025 05:00 PM