Indigenous HPV Test Validated by AIIMS and ICMR

A major breakthrough for the women healthcare, researchers from AIIMS New Delhi and the ICMR institutes as the WHO’s International Agency for Research on Cancer (IARC), France have validated the indigenous Human Papillomavirus (HPV) test that meets the international standards for the cervical cancer screening. This validated test Truenat HR-HPV-Plus, could provides the affordable and accessible screening tool for the millions of women ho are above 30 years of age.

Why Is HPV Screening Important Even After Vaccination?

While HPV vaccination helps to prevent the future infections, it does not eliminate the risk for the women who are already in age groups and vulnerable to cervical cancer.

Experts emphasize that the,

• HPV infection is the primary cause of the cervical cancer.
• Women above 30 years remain at the risk even after vaccination campaigns begin.
• Early detection via screening significantly improves the treatment outcomes.
• Large-scale HPV testing is essential for the achieving cervical cancer elimination goals.

Therefore, vaccination and the screening must work together to reduce the disease burden.

What Makes the Truenat HPV Test Special?

Among the four indigenous HPV DNA tests evaluated, Truenat HR-HPV-Plus is developed by Molbio Diagnostics and it was the only test to fully meet the international validation standards established by the WHO and IARC.

Key features includes the,

• Detects the eight high-risk HPV types.
• Covers a HPV strains responsible for nearly 95% of cervical cancer cases.
• Comparable accuracy to the internationally validated tests.
• Proven reproducibility across laboratories.
• Suitable for all the district and sub-district healthcare facilities.

This study effectively makes the Truenat India’s first internationally validated indigenous point-of-care HPV screening test.

How Was the Study Conducted?

This research was supported by the Department of Biotechnology-BIRAC under the Grand Challenges India initiative.

Researchers have evaluated total four Indian-developed HPV tests using the,

• 1,159 cervical samples.
• Confirmed precancerous lesions.
• Confirmed cervical cancer cases.
• WHO and IARC validation benchmarks.

While the Truenat fully met the international criteria, Pathodetect-7 from MyLabs has showed good sensitivity but it did not satisfy all the validation requirements.

Why Is This the Major Public Health Breakthrough?

One of the major challenges in the HPV screening has been dependence on the expensive imported technologies and specialized laboratory infrastructure.

This validated indigenous test offers the several advantages as,

• It lowers the screening costs.
• Greater accessibility in the rural and semi-urban areas.
• Faster implementation via the existing Truenat infrastructure.
• Easier adoption by the district-level healthcare workers already familiar with the platform.