Co-Diagnostics Joint Venture CoSara Initiates Clinical Studies in India for Tuberculosis Test on PCR Platform
Click to view quick news summary (Spoiler)
CoSara Diagnostics has launched clinical studies in India to evaluate its point-of-care tuberculosis test on the CoSara PCR Pro instrument, targeting rapid 30-minute real-time PCR results in decentralized settings.
Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that CoSara Diagnostics Pvt. Ltd., the Company's joint venture in India, is initiating clinical studies for the tuberculosis test on the CoSara PCR Pro® instrument.
The initiation of these clinical studies marks another critical milestone for the Co-Dx PCR platform, following the Company's previously announced shipment of PCR Pro instruments, mycobacterium tuberculosis ("TB" or "MTB") test kits and proprietary sample preparation instruments to CoSara. The decentralized point-of-care platform leverages patented Co-Primers® technology to deliver rapid, gold-standard real-time PCR results in roughly 30 minutes via a mobile application.
The CoSara PCR Pro instrument, the CoSara-branded version of the Co-Dx™ PCR Pro point-of-care instrument, is currently being deployed in select labs across India for tuberculosis testing evaluation. Co-Dx PCR platform products, including PCR test kits and the sample lysis instrument, are expected to be manufactured and distributed in India under the CoSara brand.
India accounts for a significant share of the global tuberculosis burden, making it one of the most strategically important markets for the Company's mission of closing critical gaps in access to high-quality PCR testing, especially in decentralized settings.
About Co-Diagnostics, Inc.
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform (subject to regulatory review and not currently for sale) and to identify genetic markers for use in applications other than infectious disease.
About CoSara Diagnostics Private Limited
CoSara Diagnostics Private Limited is an India-based molecular diagnostics company formed as a joint venture between Co-Diagnostics, Inc. and Synbiotics Ltd, a subsidiary of Ambalal Sarabhai Enterprises Ltd. (ASE Group), a continuation of one of the oldest and most respected Indian manufacturing institutions in operation today. CoSara was established in 2017 to manufacture and commercialize molecular diagnostic instruments and assays in India, leveraging Co-Diagnostics' proprietary PCR technology platform while operating under applicable Indian regulatory frameworks. The company is focused on expanding access to high-quality, affordable PCR-based diagnostic solutions for use in India and other permitted markets.