Panaji: A test for human papillomavirus (HPV) made at Verna has become the first Indian-made HPV test to meet international scientific benchmarks for cervical cancer screening.Every year, cervical cancer kills an estimated 80,000 Indian women. Globally, the disease claims more than 3,40,000 lives, with the overwhelming burden falling on countries that can least afford the laboratory infrastructure that reliable screening has historically demanded.A peer-reviewed study published recently in the International Journal of Cancer suggests that the test made in Goa may be part of the answer.“Cervical cancer prevention in India needs screening solutions that are accurate, affordable, and feasible for use across diverse healthcare settings. The validation of Truenat HPV-HR Plus is an important development as it demonstrates that an indigenous point-of-care HPV test can meet rigorous international criteria while addressing the practical realities of low-resource settings. Such platforms can help expand access to HPV DNA-based screening, enable earlier detection, and support India’s long-term cervical cancer elimination goals,” NCI professor emeritus and AIIMS, New Delhi’s former head of obstetrics and gynaecology department Dr Neerja Bhatla said.The Truenat HR-HPV-Plus test, manufactured by Molbio Diagnostics, has met validation criteria set by the International Agency for Research on Cancer (IARC), the cancer arm of the World Health Organisation.It is also the first “reduced-valency” HPV assay anywhere in the world to formally clear such benchmarks, a distinction with significant implications for cervical cancer screening from sub-Saharan Africa to Southeast Asia according to the research paper.The research was led by scientists at AIIMS, New Delhi and three ICMR institutes, in collaboration with IARC, with funding from the department of biotechnology’s BIRAC programme and the Gates Foundation.Standard HPV tests detect up to 14 strains of the virus. But just eight types account for roughly 95% of all cervical cancers. The Truenat device targets only these eight strains, a deliberate design choice that the study shows pays clinical dividends. By narrowing its focus, the test achieves a specificity of 91.5%, producing significantly fewer false positives than broader 14-type assays.In overstretched public health systems, fewer false positives mean fewer unnecessary referrals, less over-treatment, lower costs, and less patient anxiety.Testing 1,159 cervical samples from a WHO biorepository, the study found that Truenat HR-HPV-Plus performed on par with internationally established reference tests, with a sensitivity of 80.4% for detecting precancerous lesions. Critically, it was the only one of four Indian-made HPV tests evaluated that met IARC validation criteria. The other three HPV tests from companies in Gurugram and Secunderabad struggled with poor reproducibility between laboratories and an inability to produce valid results for half the samples tested.What sets the Truenat platform apart is not just its accuracy but its design. Compact, battery-operated, requiring no cold chain, and returning results in roughly 60 minutes, the device was built for exactly the settings where cervical cancer hits hardest.IARC is currently running a field study of the device in rural primary health centres in Tamil Nadu. Its findings are expected to inform rollout decisions not just in India but across low- and middle-income countries watching closely.The authors of the study admit that the validation of the HPV test used bio samples from Latin America and not Indian patients. The researchers said that a rigorous scale-up phase is essential before any national rollout. The device also currently lacks an internal control to verify sample adequacy, a gap they say must be addressed.“With the validation of Truenat HPV-HR Plus, India takes an important step towards making cervical cancer elimination an achievable reality. This milestone demonstrates the power of indigenous innovation to deliver globally validated solutions that can expand access to screening, strengthen public health programmes, and ultimately save lives,” said Sriram Natarajan, the chief executive officer of Molbio Diagnostics.
