By: IPP Bureau
Last updated : June 13, 2026 8:09 am
Molbio Diagnostics' Truenat HPV-HR Plus becomes the world's first formally validated reduced-valency HPV test, meeting WHO-IARC standards
India has achieved a significant milestone in its fight against cervical cancer with the successful validation of the country's first indigenous HPV DNA test that meets international standards for cervical cancer screening.
The validation, published in the International Journal of Cancer, found that Molbio Diagnostics' Truenat HPV-HR Plus met the performance criteria established by the International Agency for Research on Cancer (IARC), the specialized cancer research agency of the World Health Organization (WHO).
The achievement comes at a critical time as India expands HPV vaccination coverage and strengthens cervical cancer screening programmes for women aged above 30 years.
The multicentre study was conducted through a collaboration involving 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, IARC, France, and the Biotechnology Industry Research Assistance Council (BIRAC) under the Department of Biotechnology, Government of India.
Cervical cancer remains one of the leading causes of cancer-related deaths among women in India. The WHO recommends HPV DNA testing as the preferred screening method because of its higher sensitivity in detecting high-risk HPV infections compared with conventional cytology-based approaches such as Pap smears.
The study also establishes a global scientific benchmark by becoming the world's first formal validation of a reduced-valency HPV test. Unlike conventional assays that detect 14 high-risk HPV strains, the Truenat HPV-HR Plus targets eight of the most carcinogenic HPV types, focusing on those responsible for the vast majority of cervical cancer cases.
According to the IARC validation framework for reduced-valency assays, candidate tests must demonstrate a relative clinical sensitivity of at least 0.90 for CIN2+ lesions and 0.95 for CIN3+ lesions, along with a relative clinical specificity of 0.98 compared with a validated reference assay.
The Truenat HPV-HR Plus exceeded these benchmarks, recording a relative sensitivity of 1.03 for CIN2+ cases and 1.00 for CIN3+ cases, while maintaining a relative clinical specificity of 0.99.
Dr. Neerja Bhatla, Professor Emeritus, NCI and Former Head, Department of Obstetrics & Gynaecology, AIIMS New Delhi, said, “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.”
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."