FDA Policy Change to Allow Rapid Domestic Expansion of Co-Diagnostics COVID-19 Test

SALT LAKE CITY–(BUSINESS WIRE)–Co-Diagnostics, Inc. (Nasdaq:CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that a new FDA policy released last night aimed at expediting the availability of COVID-19 diagnostics will allow the Company to aggressively expand its presence in the U.S. market.
Co-Diagnostics was the first U.S. company to obtain a CE marking for a COVID-19 test, and international shipments have continued to escalate. In the past month, the Company has shipped its CE marked and research use Logix Smart™ COVID-19 test kits to countries all over the world. These include Italy, Germany, the United Kingdom, Turkey, Greece, the Philippines, Thailand, Australia, Paraguay, Ecuador, Israel, South Africa, and Canada, in addition to numerous shipments to customers and research institutions in the United States.
Previous domestic shipments to date have been in accordance with the FDA’s policy change on February 29, 2020 that allows U.S. CLIA laboratories to use the Company’s COVID-19, under certain conditions. Now, as a result of the change announced last night by the FDA, the Company’s test kit will soon be available for use by and marketed to a wide array of U.S. laboratories, without first requiring Emergency Use Authorization.
Co-Diagnostics CEO Dwight Egan remarked, “The ramifications of this new FDA policy are significant for our Company. This change will quickly afford Co-Diagnostics even more opportunities to serve the needs of laboratories nationwide, as we play an even larger role in responding to this pandemic. We applaud the FDA’s decision to recognize the dire need for increased access to high-quality COVID-19 tests, and to adapt as the situation demands in light of a public health emergency.
“With no known treatment or approved vaccine for the highly-infectious COVID-19, the need for accurate and rapid diagnoses has never been greater. Our cost-effective Logix Smart CODIV-19 test has been designed to run on a variety of commercially available platforms, with easy-to-interpret results in under two hours. We are confident in our ability to meet the growing demand for this diagnostic.”
See the original press release from the Food and Drug Administration here.