Pune-based Greenarray Labs launches HPV self-sampling approach to make cervical cancer screening more accessible

Pune: In an effort to make cervical cancer screening more accessible to women, Pune-based Greenarray Labs has launched CerviSens, a vaginal self-sampling kit that allows women to collect their own sample for Human Papillomavirus (HPV) testing, without requiring a speculum examination at the time of sample collection.

Cervical cancer is largely preventable through HPV vaccination, regular screening and timely treatment. However, screening continues to remain a challenge for many women. Conventional sample collection generally requires a visit to a healthcare facility, a trained healthcare professional and a pelvic examination using a speculum. For some women, awkward, embarrassment, privacy concerns or limited access to healthcare facilities can become barriers to undergoing screening.

CerviSens has been developed to simplify the sample collection process by allowing women to collect a vaginal sample themselves in privacy. The collected sample is subsequently tested in a laboratory for high-risk HPV, which is associated with the majority of cervical cancer cases.

The self-sampling approach has also undergone clinical validation. A study published in Frontiers in Medical Technology in September 2025 evaluated 203 paired self-collected and clinician-collected samples. The study reported very good agreement between the two collection methods. Using clinician-collected samples as the reference standard, CerviSens self-collected samples showed 98.0% sensitivity and 99.4% specificity for HPV detection.

Dr. Sanjay Gupte, Founder, Greenarray Labs, said, “Cervical cancer is one of the cancers where screening can make a significant difference, yet many women still do not undergo regular screening. One of the reasons is that the conventional process of sample collection may be uncomfortable or difficult to access for some women. Self-sampling provides another way for women to participate in screening while maintaining their privacy and comfort. The important next step is ensuring that women who test positive are appropriately counselled and connected to further clinical evaluation and care.”

Beyond making sample collection simpler, Greenarray Labs has also been studying the different high-risk HPV genotypes found among women across India. Its wider HPV testing programme has analysed more than 20,000 clinical samples, including a five-year multicentric study of 12,373 samples from Maharashtra, Karnataka, Odisha and Itanagar in Arunachal Pradesh.

The multicentric study found that 2.6% of the samples were positive for high-risk HPV, with approximately 63% of positive cases seen among women aged 31–50 years. HPV16 was the most frequently detected genotype, followed by HPV31, HPV33 and HPV18.

The data also showed geographical variation. High-risk HPV positivity was recorded at 2.4% in Maharashtra, 3.6% in Karnataka, 3.1% in Odisha and 6.5% in Itanagar.

Another finding was the presence of more than one high-risk HPV type in some women. Among HPV-positive samples, 34.5% showed co-infection with two or more high-risk HPV genotypes. The commonly observed combinations included HPV16 with HPV66, HPV33 with HPV58, and HPV18 with HPV33.

Dr. Preeti Helkar, Chief Genomic Scientist, Greenarray Labs, said, “HPV16 and HPV18 are widely recognised as important high-risk types, but they are not the only high-risk HPV genotypes that we encounter. Our data also showed infections involving other high-risk types as well as women carrying more than one genotype. Looking at individual genotypes gives us a more detailed understanding of HPV patterns across different populations and can contribute to surveillance as well as appropriate clinical follow-up.”

HPV DNA testing associated with the programme identifies 14 high-risk HPV genotypes – HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. While several HPV tests separately identify HPV16 and HPV18 and report other high-risk types together, individual genotyping can provide additional information on genotype distribution, persistence and co-infections.

Nitin Gupte, CEO, Greenarray Labs, said, “For screening to reach more women, it has to become easier to access and simpler to participate in. Self-sampling can help reduce some of the practical barriers associated with conventional sample collection, particularly for women who may otherwise postpone screening. Our focus is on combining easier sample collection with validated laboratory testing and ensuring that screening ultimately leads to appropriate medical follow-up wherever required.”

CerviSens is a Class A medical device manufactured under India’s Medical Devices Rules, 2017, through Form MD-5, Licence No. MFG/IVD/2020/000011, issued by the State Licensing Authority. Testing is conducted with appropriate quality controls within the scope of an NABL-accredited laboratory.

The World Health Organization’s cervical cancer elimination strategy focuses on HPV vaccination, screening and timely treatment. Making screening easier to access, particularly for women who remain outside routine screening programmes, could play an important role in increasing participation and identifying high-risk HPV infections that require further clinical evaluation.