India Validates First Indigenous HPV Test

India Validates First Indigenous HPV Test

India has validated Truenat HR-HPV-Plus, an indigenous human papillomavirus test developed by Goa-based Molbio Diagnostics for cervical cancer screening. The validation involved researchers from AIIMS New Delhi, Indian Council of Medical Research institutes, and the World Health Organization’s International Agency for Research on Cancer in France.

Human Papillomavirus and Cervical Cancer

Human papillomavirus, or HPV, is a group of viruses, and persistent infection with high-risk types is linked to cervical cancer. Truenat HR-HPV-Plus detects eight high-risk HPV types that account for about 95% of cervical cancers. Cervical cancer is a malignant disease of the cervix, which is the lower part of the uterus. India records about 127,000 new cervical cancer cases and about 80,000 deaths each year.

Validation and Testing Framework

The study was published in the International Journal of Cancer and used 1,159 cervical samples for evaluation. The assay became the first indigenous point-of-care HPV screening test to fully satisfy international validation criteria. The evaluation compared four Indian-developed HPV tests with standards used by the World Health Organization and the International Agency for Research on Cancer. The study received support from DBT-BIRAC under the Grand Challenges India initiative.

Truenat Platform and Screening Use

Truenat is a molecular diagnostic platform already used widely in India for infectious disease testing. District-level healthcare workers are familiar with the Truenat system, which supports use in screening programmes. The platform is designed for point-of-care testing, which refers to diagnostic testing performed near the patient rather than in a central laboratory. Point-of-care HPV testing is used in cervical cancer screening programmes in several countries.

Important Facts for Exams

  • HPV stands for human papillomavirus, and it includes both low-risk and high-risk types.
  • The cervix is the lower, narrow part of the uterus in the female reproductive system.
  • The International Agency for Research on Cancer is a specialised cancer agency of the World Health Organization.
  • DBT-BIRAC is linked to India’s biotechnology innovation and research support framework.

National Context

India launched an official announcement on HPV detection tests developed in India in Delhi on 23 April 2025. The event was attended by Dr Jitendra Singh, Minister of State (Independent Charge) for Science and Technology. India’s national HPV vaccination campaign covers prevention, while screening remains relevant for women above 30 years who may already be at risk of cervical cancer.

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