Key Findings
CoSara Diagnostics, a joint venture of Co-Diagnostics, Inc. (Nasdaq: CODX), has submitted the CoSara PCR Mycobacterium tuberculosis (MTB) test to India’s Central Drugs Standard Control Organization (CDSCO). Clinical evaluations of 676 samples showed an average sensitivity of 97.3% and an average specificity of 96.0% against the reference standard for TB detection. These results remained highly consistent across three different test batches.
Technical Details
The CoSara PCR MTB test is designed for use on the CoSara PCR Pro instrument, which is a CoSara-branded version of the Co-Dx PCR Pro point-of-care instrument. The platform utilizes patented Co-Primers technology to provide real-time PCR results in approximately 30 minutes. To support decentralized testing, the system employs a mobile application that generates results without requiring continuous internet connectivity; data is synchronized to the cloud once connectivity is restored.
Background & Context
The clinical study included 233 samples paired with MGIT testing to establish comparative performance. This development targets the Indian market, which the World Health Organization’s Global Tuberculosis Report 2025 identifies as having the highest tuberculosis burden globally, accounting for approximately one quarter of all cases. To prepare for the launch, Co-Diagnostics has already deployed the necessary integrated mobile and cloud infrastructure in India for secure data management and test analysis.
Significance & Outlook
CoSara expects to receive regulatory approval in the fourth quarter of 2026, enabling commercial sales in India before the end of the year. Upon CDSCO clearance, the company plans to initiate sales across India and parts of South Asia via a direct sales team and distributors. This submission occurs alongside a separate FDA 510(k) submission filed in August, placing the platform under regulatory review in two major global markets.
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