~ Supported by Grand Challenges India, BIRAC, DBT, the validation was carried through multi-centric studies in premier Indian labs.
~ Covers eight high-risk HPV genotypes, including 52 and 58 — now detectable at the point-of-care.
~ Fast turn around time- sample-to-result within an hour on Truenat –a rapid, battery-operated real-time PCR platform.
New Delhi, India, 23rd April 2025: Molbio Diagnostics Limited, a pioneer in point-of-care molecular diagnostics, recently unveiled their latest innovation, Truenat® HPV-HR Plus, which enables expanded high-risk genotype detection. The chip-based RT-PCR test allows rapid and decentralized detection of eight high-risk genotypes of human papillomavirus (HPV) – which account for over 96% of cervical cancer cases globally. The multicentric validation was supported by the Grand Challenges India, Biotechnology Industry Research Assistance Council (BIRAC)and theDepartment of Biotechnology (DBT), Government of India under its program “Validating Indigenous Human Papilloma Virus (HPV) Tests for Cervical Cancer Screening in India”, making it one of the most trusted,indigenously developed tools for cervical cancer screeningin India.
India continues to bear a disproportionate burden of cervical cancer, accounting for nearly 25% 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.
| What makes Truenat® HPV-HR Plus a Game-Changer: Expanded Genotype Panel: Most existing point-of-care HPV tests detect only 1–4 genotypes. 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, Decentralized 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 programs. |
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.”
“Truenat® HPV-HR Plus marks a significant leap in delivering precision diagnostics tailored specifically for the Indian population” said Dr Chandrasekhar Nair, CTO of Molbio Diagnostics Limited. “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”, he said.
Speaking on the occasion, — Dr. Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC) said, “At BIRAC, we are committed to strengthening India’s health innovation ecosystem by supporting indigenous solutions to pressing public health challenges. The successful validation of Truenat® HPV-HR Plus under our Grand Challenges India initiative marks a significant step toward accessible and accurate cervical cancerscreening 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 a simple, fast, and reliable test that checks for high-risk HPV infections using a portable device. 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 optimized for use at both the lab and near-patient settings.
On this special occasion, Dr. Madhavi Chandra, who leads Grand Challenges India, emphasized 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.
About Molbio Diagnostics:
Molbio Diagnostics Limited is a leader in revolutionizing point-of-care diagnostics globally. Committed to providing rapid, reliable, and robust diagnostic solutions, Molbio brings advanced healthcare technologies to the remotest areas and urban spaces alike. The company’s flagship Truenat ® real-time PCR platform is globally recognized and endorsed by the World Health Organization (WHO), enhancing infectious disease management worldwide. Molbio is dedicated to improving healthcare accessibility and quality with innovative diagnostics that meet global standards.
