Researchers found high-grade precancerous lesions or cervical cancer in 12 women who tested positive for high-risk HPV, including several with normal cytology results.
A study evaluating the Saragene Human Papillomavirus High Risk (HPV-HR) test found that molecular screening identified high-grade cervical lesions and invasive cancer in women whose cytology results were largely classified as normal.
Published in Infectious Agents and Cancer, the cross-sectional study evaluated 625 women aged 30 to 60 across hospital and community screening settings in Central Gujarat, India. Using the multiplex real-time PCR test manufactured by CoSara Diagnostics Pvt Ltd, a joint venture of Co-Diagnostics, researchers identified 20 women who tested positive for high-risk HPV genotypes.
Of the 20 HPV-positive participants, 18 had cytology reported as negative for intraepithelial lesion or malignancy, while two presented with low-grade squamous intraepithelial lesions. Subsequent colposcopy and directed biopsy identified high-grade cervical intraepithelial neoplasia (CIN II/III) in nine women and invasive cervical carcinoma in three, illustrating the potential of molecular screening to identify high-risk patients who warrant histological follow-up despite negative cytology.
“Expanding access to molecular HPV testing is an important part of strengthening cervical cancer screening, particularly in regions where access to diagnostics remains limited,” says Dwight Egan, CEO of Co-Diagnostics, in a release. “We are excited to see CoSara’s Saragene test used in published research that brings the importance of molecular screening into such clear focus. Our goal through CoSara is to make high-quality, affordable molecular diagnostics more accessible to laboratories and clinicians across India and South Asia.”
Assay Design and Diagnostic Scope
The Saragene HPV-HR test is a wet-reagent, laboratory-based multiplex real-time PCR assay designed to detect HPV-16, HPV-18, and a pooled group of 12 additional high-risk HPV genotypes. The test is authorized for clinical use in India and is not available for sale in the US.
Study investigators noted that the findings are preliminary due to the cross-sectional design and the small cohort of 20 HPV-positive patients, emphasizing that larger studies are required to confirm the diagnostic outcomes.
Co-Diagnostics also noted that the wet-reagent assay evaluated in the publication is distinct from the HPV test currently in development for its near-patient Co-Dx PCR Pro platform, which was not evaluated in this study and remains subject to regulatory review.
Regional Implementation and Screening Initiatives
The study findings coincide with growing global efforts to transition cervical screening programs toward molecular testing methods. In July 2026, the World Health Organization released guidance to help member states implement and scale HPV DNA-based testing protocols.
To support molecular testing capacity across the region, Co-Diagnostics expanded CoSara’s distribution footprint beyond India earlier this year to include Bangladesh, Pakistan, Nepal, and Sri Lanka, subject to local regulatory approvals. CoSara currently utilizes a network of more than 40 commercial distributors across India.
CoSara is presenting its molecular diagnostics portfolio, including the Saragene line, at MICROCON 2026, the 49th Annual Congress of the Indian Association of Medical Microbiologists held Oct 28 to Nov 1, 2026, at the All India Institute of Medical Sciences Nagpur. Co-Diagnostics also plans to host an educational webinar focused on HPV and cervical cancer screening for laboratory professionals, clinicians, and regional stakeholders on Nov 17, 2026.
