Follow-Up Biopsies Identified High-Grade Lesions or Cervical Cancer in 12 of 20 HPV-Positive Women, Including a Cohort with Predominantly Negative Cytology Results CoSara to Exhibit at MICROCON 2026, the Annual Congress of the Indian Association of Medical Microbiologists Co-Dx to Host HPV Screening Webinar on November 17 to Support Awareness Across South Asian Markets SALT LAKE CITY , Oct. 29, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced the publication of a peer-reviewed study using the SARAGENE® Human Papillomavirus High Risk (HPV-HR) Test manufactured by CoSara Diagnostics Pvt. Ltd. ("CoSara"), the Company's joint venture in India . The study, conducted by investigators at a local institution in Gujarat, India and published in Infectious Agents and Cancer, highlights the potential role of molecular HPV testing in identifying women who warrant further evaluation, even when cytology results are negative. Investigators used the SARAGENE® HPV-HR Test to screen samples from 625 women aged 30 to 60, collected through hospital and community screening settings in Central Gujarat, India . Twenty women tested positive for high-risk HPV; 18 had cytology results reported as negative for intraepithelial lesion or malignancy (NILM), while two had low-grade squamous intraepithelial lesions (LSIL). Subsequent colposcopy and directed biopsy identified high-grade cervical lesions ( CIN II /III) in nine women and invasive cervical carcinoma in three. The full article, "Cross-sectional assessment of high-risk HPV prevalence, genotype distribution, and associated socio-behavioural correlates among women in Central Gujarat, India ," is available at https://doi.org/10.1186/s13027-026-00796-x . "Expanding access to molecular HPV testing is an important part of strengthening cervical cancer screening, particularly in regions where access to diagnostics remains limited," said Dwight Egan , Chief Executive Officer of Co-Diagnostics . "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 ." The SARAGENE® HPV-HR Test is a wet-reagent, laboratory-based multiplex real-time PCR assay that detects HPV-16, HPV-18 and a pooled group of 12 additional high-risk HPV genotypes. The test is authorized for testing in India and is not available for sale in the United States . The investigators noted that the findings are preliminary, given the study's design and the limited number of HPV-positive participants, and that larger studies are needed to confirm these findings. The report comes as international efforts increasingly focus on expanding access to HPV-based cervical cancer screening. In July 2026 , the World Health Organization issued guidance to help countries implement and scale HPV DNA-based screening programs. CoSara's manufacturing presence in India and regional distribution footprint provide a foundation for the Company's efforts to support broader access to molecular diagnostics. Earlier this year, Co-Dx announced the expansion of CoSara's commercial and distribution territory beyond India to include Bangladesh , Pakistan , Nepal and Sri Lanka , supporting commercialization of the SARAGENE® product line subject to applicable regulatory approvals. In January 2026 , the Company reported that CoSara's network included more than 40 distributors across India . CoSara will exhibit at MICROCON 2026, the 49th Annual Congress of the Indian Association of Medical Microbiologists , taking place October 28 to November 1, 2026 , at the All India Institute of Medical Sciences (AIIMS) Nagpur in Maharashtra, India . The five-day congress is expected to bring together hundreds of microbiologists and clinical researchers from across India , along with pathology laboratory leaders and diagnostics industry representatives. CoSara's booth will feature its molecular diagnostics portfolio, including the SARAGENE® product line. Co-Diagnostics is also developing a separate HPV test for the Co-Dx PCR Pro® platform*, extending its development efforts into near-patient molecular testing. The SARAGENE® wet-reagent assay used in this study is distinct from that development program; the study did not evaluate PCR Pro or its HPV test. In recognition of World Cervical Cancer Elimination Day, Co-Dx plans to host a webinar on HPV and cervical cancer screening on November 17, 2026 , intended for healthcare providers, laboratory professionals and other stakeholders across South Asian markets. Interested parties may pre-register by emailing info@co-dx.com . *The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) h