Co-Diagnostics Inc（CODX）資訊與事件CODXCo-Diagnostics Inc

Co-Diagnostics Publishes HPV-HR Test Study Results

Co-Diagnostics announced the publication of a peer-reviewed study using the Saragene Human Papillomavirus High Risk, or HPV-HR, Test manufactured by CoSara Diagnostics, 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, while two had low-grade squamous intraepithelial lesions. Subsequent colposcopy and directed biopsy identified high-grade cervical lesions in nine women and invasive cervical carcinoma in three. The Saragene test is authorized for testing in India and is not available for sale in the U.S.

Co-Diagnostics Submits CoSara TB Test Application

Co-Diagnostics announced that CoSara Diagnostics Pvt, the company's joint venture in India, has completed its clinical performance study of the CoSara PCR Mycobacterium tuberculosis test on the CoSara PCR Pro instrument and has submitted the test to India's Central Drugs Standard Control Organization for regulatory clearance. The submission follows the Company's July 22, 2026 announcement that CoSara had initiated clinical studies for the CoSara PCR MTB test across select laboratories in India. The clinical study assessed 676 clinical samples, including 233 paired with MGIT testing that formed the basis of the reported comparative performance results. The evaluation represents an important milestone supporting CoSara's CDSCO submission and advancing the CoSara PCR MTB test toward potential commercial launch in India. The clinical evaluation was conducted in India in accordance with the applicable study requirements and resulting documentation forms part of the regulatory submission. The application is now subject to review by CDSCO, including any additional requirements that may arise during the regulatory process. Across three test batches evaluated during the clinical study, the CoSara PCR MTB test demonstrated an average sensitivity of 97.3% and an average specificity of 96.0% against the reference standard for TB detection, with highly consistent performance across batches.

Co-Diagnostics Provides Full Mosquito Surveillance Lab to Ute Indian Tribe

Co-Diagnostics has received an order from the Ute Indian Tribe Mosquito Abatement Department for a full Vector Smart mosquito surveillance laboratory installation. The order represents the company's first complete Vector Smart laboratory installation for a Native American tribe and will enable the Tribe to perform PCR testing of mosquito pools in house. The Ute Indian Tribe is located on the Uintah and Ouray Reservation in northeastern Utah. The Vector Smart platform will enable its Mosquito Abatement Department to perform molecular testing of mosquito pools locally, providing timely surveillance data to support vector-control decisions.