SALT LAKE CITY, July 22, 2026
Co-Diagnostics, Inc. has announced that its Indian joint venture, CoSara Diagnostics Pvt. Ltd., has initiated clinical studies for its tuberculosis (TB) molecular diagnostic test using the CoSara PCR Pro® platform in India. The milestone represents a major advancement in expanding access to rapid point-of-care PCR diagnostics in one of the world’s highest TB burden countries. The studies follow the successful deployment of PCR Pro instruments, MTB test kits, and proprietary sample preparation systems to selected laboratories across India for evaluation. Built on the company’s patented Co-Primers® technology, the decentralized platform is designed to deliver gold-standard real-time PCR results in approximately 30 minutes through a mobile application, supporting faster diagnosis and earlier treatment decisions. The initiative reinforces Co-Diagnostics’ strategy to improve molecular testing accessibility while strengthening India’s diagnostic capabilities for one of its most pressing infectious diseases.
Clinical Studies Advance Point-of-Care TB Diagnostics
The launch of the clinical studies marks another significant milestone in the development of the Co-Dx PCR platform, demonstrating continued progress toward decentralized molecular diagnostics. The CoSara PCR Pro® instrument, specifically branded for the Indian market, is now being evaluated in selected laboratories to validate its performance in detecting Mycobacterium tuberculosis (MTB). Designed for point-of-care settings, the platform integrates the PCR Pro instrument, TB molecular test kits, and a proprietary sample preparation system capable of delivering laboratory-quality PCR results in about 30 minutes, dramatically reducing turnaround times compared with conventional laboratory workflows. Powered by the company’s patented Co-Primers® technology, the platform aims to improve diagnostic accuracy while making advanced molecular testing more accessible in resource-limited healthcare environments. The ongoing clinical studies are expected to generate critical evidence supporting future regulatory submissions and commercialization efforts within India.
India Becomes Strategic Market for PCR Innovation
India carries one of the largest tuberculosis burdens globally, making it a strategically important market for expanding rapid molecular diagnostic testing. Through its joint venture CoSara Diagnostics, Co-Diagnostics plans to manufacture and distribute the PCR Pro platform, TB assay kits, and associated diagnostic products locally under the CoSara brand, supporting national efforts to improve TB detection and disease management. Local manufacturing is expected to strengthen supply chain resilience while improving access to affordable, high-quality PCR diagnostics across decentralized healthcare settings. The initiative aligns with India’s ongoing commitment to enhance infectious disease surveillance and accelerate diagnosis in rural and underserved regions, where rapid molecular testing can significantly improve patient outcomes and reduce disease transmission. The deployment of instruments to selected laboratories represents the first step toward broader adoption across the country following successful clinical validation and regulatory review.
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Platform Expands Future Molecular Diagnostic Opportunities
Beyond tuberculosis testing, the Co-Dx PCR platform has been developed as a versatile molecular diagnostics system capable of supporting multiple infectious disease assays using DNA and RNA detection technologies. The company’s proprietary platform also includes PCR Home®, PCR Pro®, a mobile application, and future molecular diagnostic tests currently under regulatory review in various jurisdictions, including the United States. While the platform is not yet commercially available pending regulatory authorization, Co-Diagnostics believes its scalable design and rapid turnaround capabilities position it to address growing global demand for decentralized molecular diagnostics. The India clinical program further strengthens the company’s long-term strategy to expand point-of-care PCR testing, enhance access to high-quality diagnostics, and support public health initiatives targeting infectious diseases through innovative molecular technologies.
Source: Co-Diagnostics Press release
