Laboratory will meet CGMP Requirements of FDA; Will be BSL-2 to allow enhanced in-house verification and validation activities
SALT LAKE CITY–(BUSINESS WIRE)– Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, proprietary platform for the development of diagnostic tests, announced today leasing a new and upgraded, CGMP-ready and Biological Safety Level 2 laboratory facility in Salt Lake City, Utah.
Co-Diagnostics CEO Dwight Egan remarked, “The upgraded facility is nearly perfectly appointed with the necessary amenities to immediately commence production operations. This site will help us to reduce our dependence on outside locations to complete robust validations of the Company’s products, and represents the next step in our growth as a world-class developer of molecular diagnostics. Our trained personnel will now have the capacity to manufacture high-quality products that meet the standards of the U.S. Food and Drug Administration, preparing the Company to seek future FDA approvals for sale domestically and export abroad.”
Mr. Egan continued, “This is another important milestone in the development of Co-Diagnostics as an emerging leader in the molecular diagnostics industry. We are bringing disruptive technology to the market that will dramatically improve test accuracy by reducing false positives via our CoPrimers™ technology, and facilitate multiplexing to test for a broad range of disease states in a patient in a single test which will cut costs to healthcare systems. We are excited with the opportunities ahead in the coming years.”
Biocontainment precautions are required for the safe handling of potentially dangerous biological agents in a laboratory environment. Biological Safety Levels (“BSL”) are determined by the Centers for Disease Control (“CDC”) as a way to categorize which specific controls are necessary for the containment of biological agents based on their risk, transmissibility, severity, etc. Containment levels range from the lowest, BSL-1, to BSL-4, with each level requiring increasingly strict precautions. The Company’s BSL-2 lab will allow trained staff members to conduct certain verification and validation activities on human samples in-house rather than sending investigational use test kits to other facilities. From the FDA website, a CGMP-certified facility refers the Current Good Manufacturing Practice regulations enforced by the FDA, and provides systems that assure proper design, monitoring, and control of manufacturing processes and facilities. The new facility will also house the corporate headquarters for the Company.
About Co-Diagnostics, Inc.
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that has developed and intends to manufacture and sell reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), and to sell diagnostic equipment from other manufacturers as self-contained lab systems.
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