India's first indigenously developed Human Papillomavirus (HPV) test kits for cervical cancer screening were officially launched in New Delhi on Wednesday, marking a significant advancement in the country's fight against the disease. The diagnostic kits were developed under the Department of Biotechnology's (DBT) partnership program Grand Challenges India (GCI) at the Biotechnology Industry Research Assistance Council (BIRAC).
The development comes at a critical time as cervical cancer remains the second most common cancer among Indian women, with one in five women globally suffering from the disease being Indian, according to World Health Organization (WHO) data. The country also accounts for 25% of global mortality due to cervical cancer, highlighting the urgent need for improved screening methods.
Indigenous Development Through Collaborative Research
The test kits were developed through coordinated research efforts led by the All India Institute of Medical Sciences (AIIMS) Delhi, with testing conducted at laboratories at AIIMS, the National Institute of Cancer Prevention and Research (NICPR) in Noida, and the National Institute for Research in Reproductive and Child Health (NIRRCH) in Mumbai. The research was carried out in collaboration with the WHO International Agency for Research on Cancer (IARC).
Dr. Neerja Bhatla, former head of the department of Obstetrics and Gynaecology at AIIMS Delhi and chief coordinator of the program, emphasized the unique advantage of these kits: "The key feature of these kits is the inclusion of only the seven-eight most common cancer-causing types that will allow a very efficient and cost-effective screening programme which will be most suitable for India."
The study, titled 'Validation of Indigenous Human Papillomavirus Tests for Cervical Cancer Screening in India (i-HPV)', validated the rapid, point-of-care, RTPCR-based HPV diagnostic test kits in premier research and development laboratories across India.
Advantages Over Traditional Screening Methods
Currently available methods for cervical cancer screening include Visual Inspection with Acetic Acid (VIA), Papanicolaou test (Pap smear), and HPV DNA testing. Each of these methods has limitations in the Indian context.
"Regular population screening by Pap smears has been successfully implemented in the developed world. Nevertheless, it is costly, resource-intensive and only moderately sensitive," Dr. Bhatla explained. "VIA screening requires considerable training and re-training for quality assurance and has high false positivity rates with programmatic challenges."
The new RTPCR-based HPV testing kits offer significant advantages, particularly in light of expanded diagnostic capabilities following the COVID-19 pandemic. Dr. Bhatla noted, "Given the enhancement of RTPCR-based diagnostic facilities across the nation in the post-COVID era, the introduction of sensitive RTPCR-based HPV testing kits might prove to be cost-effective screening method over classical HPV DNA and Pap smear for deployment in the national cancer screening programme."
Alignment with Global Cervical Cancer Elimination Strategy
The introduction of these indigenous HPV test kits aligns with the WHO's Global Declaration for Cervical Cancer Elimination, which recommends a transition to HPV testing in all countries. Under this strategy, only two tests in a lifetime—at age 35 and again by age 45—would be sufficient for screening.
The WHO has set a target to screen 70% of eligible women by 2030, and these new test kits could play a crucial role in helping India achieve this goal. The cost-effectiveness and specificity of the kits to the most common HPV types in India make them particularly valuable for widespread implementation in national screening programs.
Public Health Impact and Future Prospects
The launch of these indigenous HPV test kits represents a significant step forward in India's efforts to combat cervical cancer. Early detection through effective screening is crucial for improving survival rates and reducing the burden of the disease.
With the high incidence of cervical cancer in India and the associated mortality rate, these locally developed, cost-effective screening tools have the potential to make a substantial impact on public health outcomes. The utilization of existing RTPCR infrastructure established during the COVID-19 pandemic further enhances the feasibility of implementing these tests on a national scale.
As India continues to strengthen its healthcare infrastructure and expand access to preventive services, these indigenous HPV test kits offer a promising solution for addressing one of the most significant cancer burdens facing Indian women today.
