Co-Diagnostics Inc. (NASDAQ:CODX) is getting closer to selling its rapid tuberculosis test in India. On Tuesday, the company said its joint venture has submitted a formal regulatory filing backed by strong clinical performance data, moving the point-of-care testing technology one step nearer to launch in South Asia.
CoSara Diagnostics Pvt. Ltd., Co-Diagnostics' joint venture in India, filed an application with India's Central Drugs Standard Control Organization. The application seeks regulatory clearance for the CoSara PCR Mycobacterium tuberculosis test on the CoSara PCR Pro instrument.
Strong Trial Outcomes Drive Regulatory Filing
The regulatory submission comes after an extensive clinical evaluation that began across select Indian laboratories in July 2026. The trial looked at 676 patient samples, including 233 specimens paired with MGIT testing to establish comparative performance metrics.
Across three evaluated batches, the diagnostic test showed an average sensitivity of 97.3% and an average specificity of 96.0% against the tuberculosis reference standard. The evaluation also confirmed consistent diagnostic performance across all test lots, a critical milestone ahead of a planned commercial rollout.
Addressing Critical Healthcare Needs In India
India is an essential market for the molecular diagnostics developer. According to the World Health Organization's Global Tuberculosis Report 2025, the nation accounts for approximately one-quarter of all global tuberculosis infections, the highest burden worldwide.
The portable CoSara PCR Pro system uses proprietary Co-Primers technology to deliver accurate real-time PCR results in about 30 minutes via a mobile application. It bypasses the need for centralized laboratory infrastructure. Co-Diagnostics also established localized cloud and mobile digital architecture in India. This framework lets the platform's mobile application generate test results in decentralized settings without continuous internet connectivity, synchronizing data once connectivity resumes.
Commercial Rollout Planned Before Year-End
Co-Diagnostics and its joint venture partner anticipate securing regulatory authorization from Indian officials during the fourth quarter of 2026. Regulatory clearance will allow CoSara to commence commercial product sales in India prior to the end of the year.
CODX Price Action: Co-Diagnostics shares were up 0.02% at $0.54 during premarket trading on Tuesday, according to market data.
