India has reached a landmark in cervical cancer prevention after the country’s first indigenous HPV DNA test was successfully validated against international standards for cervical cancer screening.

 

A multicentre study published in the International Journal of Cancer has confirmed that Molbio Diagnostics’ Truenat HPV-HR Plus meets the stringent validation criteria set by the International Agency for Research on Cancer (IARC), the cancer research arm of the World Health Organization (WHO).

 

The study brings together leading institutions including All India Institute of Medical Sciences (AIIMS) New Delhi, ICMR-National Institute of Cancer Prevention and Research, ICMR-National Institute for Research in Reproductive and Child Health, and the Biotechnology Industry Research Assistance Council (BIRAC) under India’s Department of Biotechnology, alongside international collaborators.

 

Cervical cancer remains one of the leading causes of cancer deaths among women in India, and WHO recommends HPV DNA testing as the preferred screening method due to its higher sensitivity compared to Pap smears.

 

The validation arrives at a critical moment as India scales up HPV vaccination and expands screening programmes for women over 30, strengthening its broader cervical cancer elimination strategy.

 

Significantly, the study marks the world’s first formal validation of a reduced-valency HPV test—designed to detect only eight high-risk cancer-causing strains instead of the usual 14—setting a new global benchmark for affordable, point-of-care screening tools.

 

Under IARC criteria, a candidate test must demonstrate a relative clinical sensitivity of ≥0.90 for CIN2+ and ≥0.95 for CIN3+, with specificity ≥0.98 compared to a reference assay. The Truenat HPV-HR Plus not only met these thresholds but exceeded them, showing a relative sensitivity of 1.03 for CIN2+ and 1.00 for CIN3+ cases, while maintaining a specificity of 0.99.

 

By focusing on eight key high-risk HPV types, the assay avoids detecting transient, low-risk infections often picked up by broader 14-valent tests—significantly reducing false positives, unnecessary referrals, and patient anxiety.

 

“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," said Neerja Bhatla, Former Head, Department of Obstetrics & Gynaecology, AIIMS New Delhi.

 

Molbio Diagnostics says the breakthrough strengthens its mission to democratise molecular diagnostics and expand access to high-quality screening tools.

 

“With the validation of Truenat HPV-HR Plus, India takes an important step towards making cervical cancer elimination an achievable reality. At Molbio, our mission has always been to democratise access to high-quality molecular diagnostics. 

 

"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, Chief Executive Officer, Molbio Diagnostics.

 

With the Truenat platform already widely deployed across India for infectious disease testing, the HPV-HR Plus assay is expected to be rapidly integrated into national screening programmes—boosting coverage, especially in underserved regions, and advancing India’s push to eliminate cervical cancer as a public health threat.