The Department of Biotechnology (DBT), through its Grand Challenges India (GCI) initiative at BIRAC, has announced the successful scientific review and validation of India’s first indigenously developed Human Papillomavirus (HPV) test kits for cervical cancer screening. These test kits, developed by Molbio Diagnostics Limited, Bangalore, and Mylab Discovery Solutions Pvt. Ltd., Pune, are a significant leap forward in improving cancer diagnostics in the country.

The HPV point-of-care test kits underwent rigorous validation by a research team at the All India Institute of Medical Sciences (AIIMS), New Delhi, in collaboration with the National Institute of Cancer Prevention and Research (NICPR), Noida, and the National Institute for Research in Reproductive and Child Health (NIRRCH), Mumbai. The validation process also included a partnership with the World Health Organization’s International Agency for Research on Cancer (IARC).

The kits, which employ a chip-based RT-PCR testing method, facilitate rapid and decentralised detection of eight high-risk HPV genotypes - accounting for over 96% of cervical cancer cases worldwide. This technological advancement provides an affordable and efficient solution for widespread cervical cancer screening, particularly in resource-limited settings.

Jitendra Kumar, Managing Director of BIRAC, underscored the critical importance of accessible and accurate diagnostic tools. “The validation of Truenat® HPV-HR Plus (Molbio) and Patho detect (Mylab) marks a significant achievement in enhancing cervical cancer screening for women across India. This initiative highlights the strength of indigenous innovation in driving early detection and saving lives,” he stated.

Cervical cancer continues to be a major health challenge in India, accounting for nearly 25% of global cases. With more than 1,23,000 new diagnoses and approximately 77,000 deaths annually, it remains the second most prevalent cancer among Indian women, despite being preventable through timely screening.

In line with the Global Declaration for Cervical Cancer Elimination, the World Health Organization (WHO) advocates for the transition to HPV testing in all countries. The WHO’s goal is to ensure that by 2030, 70% of eligible women will be screened through HPV testing at age 35 and again at age 45, with only two tests required over a lifetime.