ICMR Validates Made-in-India TB Tests, Paving Way for Cheaper, Faster Detection

According to ICMR, this could cut testing costs by nearly one-fifth and help public sector laboratories scale up molecular testing without additional infrastructure investment.

The Indian Council of Medical Research (ICMR) has validated two indigenously developed tuberculosis (TB) diagnostic tools that promise to expand testing access and reduce costs, marking a significant step in India’s TB elimination efforts.

Among the validated tools is Quantiplus MTB FAST detection kit, developed by Huwel Lifesciences in Telangana. It is the first open system RT-PCR assay for lung TB detection that can operate on any existing PCR machine, removing dependence on proprietary platforms.

“This means, laboratories across India, even those without specialised ‘closed’ equipment, can now expand rapid molecular TB testing using standard PCR machines,” a source said.

The Quantiplus kit can test up to 96 samples at once and is designed for sputum-based detection in adults. According to ICMR, this could cut testing costs by nearly one-fifth and help public sector laboratories scale up molecular testing without additional infrastructure investment.

The second validated product, UniAMP MTB Nucleic Acid Test Card, also by Huwel Lifesciences, enables TB diagnosis using non-invasive tongue swabs instead of sputum samples. The ICMR noted that this marks a major improvement in patient-friendly diagnostics, especially benefiting children and the elderly who face difficulty producing sputum.

An official source said the approach could make doorstep TB testing feasible and support large-scale community screening programs, improving early detection and access to care.

“Through ICMR’s rigorous and streamlined validation process, we are ensuring that innovative TB diagnostics are validated quickly. This effort reflects India’s resolve to strengthen indigenous research and innovation, close gaps in early detection and treatment, and ultimately help the country to move closer to eliminating tuberculosis as a public health challenge,” said Dr. Nivedita Gupta, Head, Communicable Diseases Division, ICMR.

These validations follow upgrades to existing tools such as Truenat and PathoDetect, which support decentralised high-precision Nucleic Acid Amplification Tests (NAAT). According to ICMR, expanding such technologies can reduce diagnostic delays and enable effective treatment of both drug-sensitive and drug-resistant TB cases.

The validation of these homegrown innovations underscores efforts to strengthen India’s domestic scientific ecosystem and expand access to affordable, reliable TB testing.

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