Why is India's first validated HPV test being seen as a major cancer-screening breakthrough?

India has validated its first indigenous HPV DNA test for cervical cancer screening, a development researchers say could make testing more affordable and accessible across the country.

The test, Truenat HPV-HR Plus, developed by Goa-based Molbio Diagnostics, was cleared in a multicenter study involving AIIMS New Delhi, ICMR institutes, and the World Health Organization’s International Agency for Research on Cancer.

The finding comes as India expands its HPV vaccination drive and continues to look for a scalable screening tool for women who remain at risk, especially those above 30 years of age.

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One contender clears the bar

According to the studies, the test met international validation criteria and was the only one among four indigenous HPV DNA assays to satisfy the full benchmark.

The evaluation used 1,159 cervical samples, including confirmed cases of precancerous lesions and cervical cancer, and assessed the tests against WHO and IARC standards.

Researchers said the Truenat assay detects eight high-risk HPV types responsible for about 95% of cervical cancers and showed accuracy comparable to internationally validated reference tests.

The other three indigenous assays did not meet the validation thresholds, with some falling short on sensitivity or reproducibility.

The case for testing closer to home

The timing of the validation matters because the World Health Organization recommends HPV DNA testing as the preferred screening method, but adoption in India has been limited by high costs, imported technologies, and infrastructure requirements.

In that context, the new indigenous platform is being positioned as a point-of-care option that could be used at district and sub-district facilities with minimal training.

Dr. Neerja Bhatla, professor emeritus at AIIMS, said cervical cancer prevention needs screening solutions that are “accurate, affordable, and feasible for use across diverse healthcare settings.”

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The road to wider screening

Molbio Diagnostics said the validation could help broaden screening coverage and support India’s cervical cancer elimination goals.

Chief executive Sriram Natarajan said, “With the validation of Truenat HPV-HR Plus, India takes an important step towards making cervical cancer elimination an achievable reality.”

The company also said the Truenat platform is already widely deployed across India for infectious disease testing, which could help its HPV test integrate more quickly into existing screening programs.

Researchers and public health officials have said affordable native testing will be crucial if India is to improve early detection and reduce cervical cancer deaths over time.

FAQs

Q1: What is India’s first validated indigenous HPV test for cervical cancer screening?

Ans: India’s first validated indigenous HPV DNA test is Truenat HPV-HR Plus, developed by Molbio Diagnostics, which has met international standards for detecting high-risk HPV strains linked to cervical cancer.

Q2: Why is the validation of the Truenat HPV test important?

Ans: The validation could make cervical cancer screening more affordable and accessible in India, helping expand early detection efforts, particularly in underserved and rural areas.