Co-Diagnostics Inc. (NASDAQ:CODX) said on Tuesday that it moved closer to launching its point-of-care tuberculosis testing technology in South Asia after its joint venture submitted a formal regulatory filing backed by strong clinical performance data.
CoSara Diagnostics Pvt. Ltd., the company’s joint venture in India, filed an application with India’s Central Drugs Standard Control Organization seeking regulatory clearance for the CoSara PCR Mycobacterium tuberculosis test on the CoSara PCR Pro instrument.
Strong Trial Outcomes Drive Regulatory Filing
The regulatory submission follows the completion of an extensive clinical evaluation initiated across select Indian laboratories in July 2026.
The clinical trial evaluated 676 patient samples, incorporating 233 specimens paired with MGIT testing to establish comparative performance metrics.
Across three evaluated batches, the diagnostic test demonstrated 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, marking a critical milestone ahead of a planned commercial rollout.
Addressing Critical Healthcare Needs In India
India represents an essential market for the molecular diagnostics developer, as the nation accounts for approximately one-quarter of all global tuberculosis infections—the highest burden worldwide, according to the World Health Organization’s Global Tuberculosis Report 2025.
The portable CoSara PCR Pro system leverages proprietary Co-Primers technology to deliver accurate real-time PCR results within approximately 30 minutes via a mobile application, bypassing the need for centralized laboratory infrastructure.
Co-Diagnostics also established localized cloud and mobile digital architecture in India.
This framework enables the platform’s mobile application to 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 Benzinga Pro data.
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