Molecular diagnostics firm Co-Diagnostics has achieved a significant regulatory milestone in India, even as it contends with a difficult period for its U.S.-listed shares. The company’s joint venture, CoSara Diagnostics, has been granted the official manufacturing license for its PCR-Pro instrument by Indian authorities, marking a pivotal step in its international strategy.
Regulatory Progress and Quality Assurance
The Central Drugs Standard Control Organisation (CDSCO) of India issued the license for the manufacture and distribution of the PCR-Pro platform last Thursday. This authorization provides the final regulatory clearance needed for the Ranoli-based facility to commence commercial marketing of the instrument within the Indian market.
This development was closely preceded by another critical certification. Just one day prior, the manufacturing site received ISO 13485:2016 accreditation, verifying its compliance with international quality management standards for medical devices.
While the core instrument is now cleared for sale, the accompanying test kits remain under review. Specific PCR assays, including those for Tuberculosis and HPV, are currently undergoing separate regulatory evaluations. These tests must complete their own approval processes before they can be distributed as in-vitro diagnostics.
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Nasdaq Delisting and Equity Consolidation
These operational advances stand in contrast to the company’s recent capital market difficulties. Trading on the Nasdaq was terminated on January 14 after the company failed to meet the exchange’s continued listing requirements. Co-Diagnostics stock now trades on the OTC Markets, specifically within the “Pink Limited Information” tier.
A 1-for-30 reverse stock split executed in early January was intended to boost the share price to regain compliance with Nasdaq rules. This strategic move ultimately proved unsuccessful, leading to the delisting. The exchange proceeded with the removal despite management’s stated intention to appeal the decision.
Upcoming Financial Disclosure and Pipeline
Investors are now looking ahead to the next significant date: March 19. On this day, Co-Diagnostics is scheduled to release its financial results for both the fourth quarter and the full fiscal year 2025. This report will offer the first comprehensive look at the company’s financial health following the reverse split and the transition to the OTC market.
Concurrently, the company continues to advance its clinical development pipeline. Work is ongoing on a combined respiratory test targeting COVID-19, influenza, and RSV. Successful development of this multiplex assay is intended to form the basis for future regulatory submissions to the U.S. Food and Drug Administration (FDA).
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