Co-Diagnostics Clears Key Manufacturing Hurdle for New Diagnostic Platform
05.02.2026 - 12:42:04
Co-Diagnostics has achieved a significant regulatory milestone, advancing its strategy to scale global manufacturing. The company announced that its Indian joint venture, CoSara, has secured ISO 13485:2016 certification for its Vadodara facility. This accreditation is a fundamental prerequisite for the planned international rollout of Co-Diagnostics' new PCR testing systems.
The ISO certification, granted on February 4, covers quality management for the design and manufacture of medical devices. For Co-Diagnostics, this greenlights production at the Indian site, which is slated to manufacture the Co-Dx PCR Pro and PCR Home platforms. These systems are designed for decentralized, point-of-care testing.
A central component of the strategy involves leveraging India's "Make in India" initiative. By sourcing components locally rather than importing them, the company aims to substantially reduce manufacturing costs. Management believes this cost advantage will be critical for enhancing price competitiveness in the global diagnostics market.
The platform itself remains under review by the U.S. Food and Drug Administration (FDA) and other international regulators. Technical teams are currently finalizing software for tuberculosis (MTB) and HPV tests while preparing the required clinical performance studies. Successful completion of these studies is mandatory before the systems can be launched commercially.
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Financial and Market Context
The company's recent history in public markets has been eventful. In early January, Co-Diagnostics executed a 1-for-30 reverse stock split in an effort to meet the Nasdaq's minimum bid price requirement. Despite this move, trading of its common stock moved to the OTC Pink Market on January 14. Company leadership has stated its intention to challenge the delisting decision in a hearing before a Nasdaq panel, with the goal of reinstating its listing on the main exchange.
Investor attention is now focused on two key upcoming events: the timeline for FDA submissions and the subsequent market launch of the PCR Pro instrument, and the financial update scheduled for March 26. On that date, the company is expected to release its fourth-quarter and full-year 2025 results, which should provide concrete details on its financial stability and operational progress.
Key Data Points:
* Certification: ISO 13485:2016 awarded to joint venture CoSara on February 4.
* Production Target: Manufacturing of PCR Pro and PCR Home systems in India.
* Current Trading Venue: OTC Pink Market since January 14, following Nasdaq delisting.
* Upcoming Financial Report: Q4 and full-year 2025 results anticipated on March 26.
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