By Surabhi Gupta
New Delhi: In a major milestone for women’s health in India, the Department of Biotechnology (DBT), in partnership with Grand Challenges India (GCI) and the Biotechnology Industry Research Assistance Council (BIRAC), has launched India’s first indigenously developed, point-of-care RT-PCR-based HPV diagnostic test kits. These affordable kits aim to revolutionise the early detection of cervical cancer, which remains the second most common cancer among Indian women.
National Health Priority
Cervical cancer places a disproportionately high burden on India. According to the World Health Organization (WHO), one in every five women with cervical cancer globally is from India. Late diagnosis often leads to severe outcomes, with India accounting for nearly 25% of the world's cervical cancer deaths. While existing visual inspection methods like VIA/VILI and Pap smears have played a role, they require significant training and often lack accuracy. This makes them less feasible for large-scale, national implementation.
The new indigenous RT-PCR kits, however, offer a solution: accurate, scalable, and cost-effective diagnostics, validated to meet scientific and global standards.
Multi-Institutional Collab and Field Validation
The kits are the result of a robust multi-institutional collaboration under the project titled “Validation of Indigenous Human Papillomavirus Tests for Screening Cervical Cancer in India (i-HPV)”. Partner institutions included AIIMS New Delhi, NICPR Noida, NIRRCH Mumbai, and WHO’s International Agency for Research on Cancer (IARC). Crucially, the kits were tested not just in advanced R&D labs but also under “real-world” field conditions, using minimally trained healthcare workers.
“The HPV kits available internationally are expensive; we cannot afford them in our national programs,” said Padma Shri Dr. Neerja Bhatla, Head of Obstetrics and Gynecology at AIIMS. “We needed an indigenous alternative — not just cheaper, but just as reliable. That’s where validation becomes key. We rigorously tested two of these kits in collaboration with WHO and three top laboratories. The results were very encouraging.”
Smarter, Targeted Testing
The innovation lies not just in affordability, but also in clinical specificity. The kits are designed to detect only the 7–8 high-risk HPV types most commonly linked to cervical cancer. “There are many types of HPV, but not all cause disease. Some types contribute to less than 1% of cases. This test focuses on those that truly matter,” Dr. Bhatla explained. “This specificity reduces false positives and makes the screening program more efficient.”
Importantly, testing was conducted in low-infrastructure settings with entry-level technicians, simulating rural healthcare environments. “This was done deliberately. We wanted to ensure that the kits would work across the country, even in areas with limited resources,” she added.
Post-COVID Advantage
The expansion of RT-PCR testing infrastructure during the COVID-19 pandemic has created a powerful foundation. This existing network can now be repurposed for nationwide cervical cancer screening, accelerating rollout and access.
Union Minister Dr. Jitendra Singh, who launched the initiative, called it a key step in the Atmanirbhar Bharat (self-reliant India) movement. “This initiative isn’t just about a test kit — it’s about saving lives, enabling early intervention, and empowering our youth, especially young girls, to lead healthier, longer lives. It’s a national responsibility,” he said.
The project aligns with WHO’s Global Strategy for the Elimination of Cervical Cancer, which recommends that 70% of women be screened with an HPV test at least twice in their lifetime — once at age 35 and again at 45 — by 2030. With test kits like PythoDetect and Truenat HPV (now upgraded from 4-type to 8-type detection) entering the mainstream, India is poised to become a global leader in low-cost, high-impact diagnostics.
“These kits will not only reduce our dependency on imports but also serve the global south, especially in African countries with high cervical cancer burdens,” said Dr. Bhatla. “You can’t promote testing without availability. Now that we have the kits, we can focus on awareness and access.”
Bridging the Awareness Gap
While technology is essential, awareness remains a critical barrier. Dr. Bhatla stresses that HPV screening should begin only after age 30, as most infections clear on their own before that.
“Only about 10% of HPV infections persist, and it’s these women who are at risk. Screening helps detect these persistent infections early,” she said. “Now, we also have battery-operated outpatient tools for treatment. Even urban women can get care before it progresses to cancer.” With wider rollout expected soon and scale-up of production underway, these test kits are a crucial step toward meeting India’s Sustainable Development Goals (SDGs) for health.
