CoSara HPV Test Study Highlights Cervical Cancer Screening

SALT LAKE CITY, Utah, October 29, 2026

SARAGENE HPV Screening Study Identifies High-Risk Cases

The peer-reviewed study, titled Cross-sectional assessment of high-risk HPV prevalence, genotype distribution, and associated socio-behavioural correlates among women in Central Gujarat, India, investigated high-risk HPV prevalence and genotype distribution among women participating in cervical cancer screening. Researchers used the SARAGENE HPV-HR Test, a laboratory-based molecular diagnostic assay manufactured by CoSara Diagnostics. Of the 625 women screened, 20 participants tested positive for high-risk human papillomavirus (HPV). Interestingly, 18 of these HPV-positive women had cytology results classified as negative for intraepithelial lesion or malignancy (NILM), while two participants showed low-grade squamous intraepithelial lesions (LSIL). Following the initial screening, the women underwent additional clinical evaluation through colposcopy and directed biopsy. The follow-up investigations identified cervical intraepithelial neoplasia grades II and III (CIN II/III) in nine women, while three women were diagnosed with invasive cervical carcinoma. These observations demonstrate why HPV-positive individuals may require appropriate follow-up even when initial cytology findings appear negative. The study also highlights the potential contribution of molecular testing to identifying women who could benefit from additional diagnostic assessment.

Real-Time PCR Technology Supports High-Risk HPV Detection

The SARAGENE HPV-HR Test is a wet-reagent, laboratory-based multiplex real-time polymerase chain reaction (PCR) assay designed to detect important high-risk HPV genotypes associated with cervical cancer development. The test specifically identifies HPV-16 and HPV-18, two genotypes strongly associated with cervical cancer, while simultaneously detecting a pooled group of 12 additional high-risk HPV types. Human papillomavirus is a common sexually transmitted viral infection, and persistent infection with high-risk HPV genotypes is a major cause of cervical cancer. Molecular PCR testing works by detecting specific viral genetic material in collected clinical samples, allowing laboratories to identify high-risk infections before advanced cervical abnormalities become clinically apparent. Unlike cytology-based screening, which examines cervical cells for abnormal changes, HPV molecular testing identifies the presence of high-risk viral genotypes. These approaches can provide complementary information for cervical cancer screening and clinical decision-making. According to Co-Diagnostics, the SARAGENE HPV-HR Test is authorized for testing in India and is not available for commercial sale in the United States. The study evaluated the SARAGENE laboratory assay and did not assess the company’s separate investigational Co-Dx PCR Pro platform.

Expanding Access to Molecular Cervical Cancer Screening

The publication comes amid growing international efforts to improve access to HPV-based cervical cancer screening and early detection services. In July 2026, the World Health Organization issued updated guidance supporting the implementation and expansion of HPV DNA-based screening programmes. Increasing access to reliable molecular diagnostics is particularly important in countries where healthcare infrastructure, laboratory availability and screening participation can vary significantly between urban and rural communities. Through its manufacturing operations and distribution network in India, CoSara Diagnostics aims to expand access to molecular diagnostic testing across India and other South Asian markets. The joint venture has also expanded its commercial and distribution territory to Bangladesh, Pakistan, Nepal and Sri Lanka, subject to applicable regulatory approvals. CoSara is scheduled to showcase its molecular diagnostic portfolio, including the SARAGENE product line, at MICROCON 2026, the 49th Annual Congress of the Indian Association of Medical Microbiologists, taking place at AIIMS Nagpur, Maharashtra, from October 28 to November 1, 2026. Co-Diagnostics has also announced plans to conduct an HPV and cervical cancer screening awareness webinar on November 17, 2026, for healthcare providers and laboratory professionals across South Asian markets.

The publication represents an important development for Co-Diagnostics and its joint venture CoSara Diagnostics, highlighting the potential contribution of molecular HPV testing to cervical cancer screening strategies. The findings also reinforce the importance of combining appropriate screening methods with follow-up diagnostic procedures to identify women who may require further medical assessment. However, the investigators emphasized that the findings are preliminary because only 20 participants tested positive for high-risk HPV, and larger studies are required to confirm the observations. The study does not establish the overall diagnostic accuracy or clinical superiority of the SARAGENE test over cytology. Nevertheless, the research adds to the growing evidence supporting molecular HPV screening as an important component of cervical cancer prevention and early detection programmes.

Source: Co-Diagnostics press release