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Molbio Diagnostics unveils Truenat HPV-HR Plus, aims to enhance cervical cancer screening

The new test covers eight high-risk HPV genotypes, including 52 and 58 — now detectable at the point-of-care

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Molbio Diagnostics recently unveiled its latest innovation, Truenat HPV-HR Plus, which enables expanded high-risk genotype detection. The chip-based RT-PCR test allows rapid and decentralised detection of eight high-risk genotypes of human papillomavirus (HPV) – which account for over 96 per cent of cervical cancer cases globally. The multicentric validation was supported by the Grand Challenges India, Biotechnology Industry Research Assistance Council (BIRAC) and the Department of Biotechnology (DBT), Government of India under its programme “Validating Indigenous Human Papilloma Virus (HPV) Tests for Cervical Cancer Screening in India.”

India continues to bear a disproportionate burden of cervical cancer, accounting for nearly 25 per cent of global cases. With more than 1,23,000 new diagnoses and around 77,000 deaths each year, the disease remains the second most common cancer among Indian women — despite being preventable through timely screening.Highlighting the importance of developing homegrown solutions, Rajesh S. Gokhale, Secretary, Department of Biotechnology, Ministry of Science & Technology, Government of India said, “Truenat HPV-HR Plus represents the kind of diagnostic innovation we need — dependable, scientifically rigorous, locally developed, and built to serve our public health system. It’s a huge step forward in strengthening cervical cancer screening across India.”

Dr Chandrasekhar Nair, CTO of Molbio Diagnostics, “By including regionally prevalent high-risk HPV genotypes such as HPV 52 and 58, we aim at supporting India’s cervical cancer elimination efforts, targeting women’s health in urban and rural areas alike.”

Speaking on the occasion, Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC) said, “The successful validation of Truenat HPV-HR Plus under our Grand Challenges India initiative marks a significant step toward accessible and accurate cervical cancer screening for women across the country. This test reflects the power of indigenous innovation in advancing early detection and saving lives.”

While presenting the evidence gathered during the clinical validation, Dr Neerja Bhatla, Head of Department, Obstetrics and Gynaecology, AIIMS elaborated upon the high sensitivity and specificity of the test– meeting all parameters of the study.

Truenat HPV-HR Plus is designed to work with cervical swab samples collected by a clinician, it gives highly accurate results in just 60 minutes. Easy to use and with high stability at room temperature, it requires minimal biosafety and is optimised for use at both the lab and near-patient settings.

On this special occasion, Dr Madhavi Chandra, who leads Grand Challenges India, emphasised the importance of creating affordable, accurate, and user-friendly diagnostic tools, especially for resource-limited settings. The Truenat HPV-HR Plus aims to overcome the shortcomings of current diagnostic methods, including high costs, complex workflows, and dependence on advanced equipment. These crucial innovations will benefit women and children in India and around the world.

Key highlights of Truenat HPV-HR Plus

Expanded genotype panel: Truenat HPV-HR Plus detects 8 high-risk types, including those disproportionately affecting Indian women.

Regionally relevant detection: HPV 16, 18,  52 and 58 are highly prevalent in Asia, while HPV 35 is common in Africa — all now covered by the new test.

Rapid, decentralised testing: Results are delivered in under an hour using Molbio’s battery-operated Truenat Test, ideal for use at point-of-care settings.

Indigenous Innovation: Developed and manufactured in India, the test supports national public health goals, including the WHO’s cervical cancer elimination strategy and India’s own cancer control programmes.

 

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