India has achieved a significant milestone in cervical cancer prevention with the successful validation of the country’s first indigenous HPV DNA tests, which meet international standards for cervical cancer screening.
Published in the International Journal of Cancer, a multicentre study involving leading Indian and international institutions found that Molbio Diagnostics Truenat HPV-HR Plus met the validation criteria established by the International Agency for Research on Cancer (IARC), the specialised cancer research agency of the World Health Organization (WHO).
The study marks the world’s first formal validation of a reduced-valency HPV test– one that deliberately targets only the eight most cancer-causing strains rather than the usual 14- setting a global scientific benchmark for evaluating this new class of affordable, point-of-care screening tools.
The study was conducted through collaboration between leading Indian and international institutions, including AIIMS New Delhi, ICMR-National Institute of Cancer Prevention and Research, ICMR-National Institute for Research in Reproductive and Child Health, the International Agency for Research on Cancer, France, and the Biotechnology Industry Research Assistance Council under the Department of Biotechnology, Government of India.
Dr. Neerja Bhatla, Professor Emeritus, NCI and Former Head, Department of Obstetrics & Gynaecology, AIIMS New Delhi, said, “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.”
Based on the validation framework of the International Agency for Research on Cancer (IARC) for reduced-valency assays, a candidate HPV test must demonstrate a relative clinical sensitivity of ≥0.90 for CIN2+ and ≥0.95 for CIN3+ alongside a relative clinical specificity of ≥0.98 compared to a validated reference assay. While classical validation models traditionally mandated detection of 14 high-risk HPV types, the IARC expert consultation established that reduced-valency tests targeting the core carcinogenic types can achieve primary screening goals more efficiently. In this study, the 8-valent Truenat assay not only met the adapted Meijer non-inferiority clinical thresholds but also exceeded performance expectations by demonstrating a relative sensitivity of 1.03 for CIN2+ cases and 1.00 for CIN3+ cases.
By narrowing its targets to 8 high-risk types, the assay avoids detecting transient, low-risk infections that 14-valent tests often detect. It successfully maintained an exceptional relative clinical specificity (0.99), demonstrating its potential to drastically reduce unnecessary secondary referrals, costly over-triage, and patient anxiety. This targeted approach offers a highly sustainable model for primary cervical cancer screening, particularly within low- and middle-income countries where optimizing limited healthcare resources is paramount.
When contextualized against existing primary screening modalities in resource-limited settings, the clinical specificity profile of the 8-valent Truenat assay offers a profound operational advantage over both Pap smears and VIA. By replacing highly subjective visual interpretation with automated molecular amplification, it eliminates human error and drives down false-positive rates to bring centralized laboratory clarity into a rugged, decentralized package
Mr Sriram Natarajan, Chief Executive Officer, Molbio Diagnostics, said, “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.”
With the Truenat platform already widely deployed across India and routinely used by healthcare workers for infectious disease testing, Truenat HPV-HR Plus can be rapidly integrated into cervical cancer screening programmes. The availability of an affordable, indigenous, internationally validated HPV DNA test has the potential to expand screening coverage, particularly in underserved settings, and support India’s efforts to eliminate cervical cancer as a public health problem.
