Co-Diagnostics' COVID-19 test gets emergency-use go-ahead from FDA

Co-Diagnostics, Inc., a molecular diagnostics company based in Salt Lake City, announced last week that its Logix Smart Coronavirus COVID-19 test has obtained emergency-use authorization (EUA) by the Food and Drug Administration to be used for the diagnosis of SARS-CoV-2. The company’s test can now be used by clinical laboratories certified under Clinical Laboratory Improvement Amendments to detect the presence of the virus that causes COVID-19 and is available for purchase from the company’s Utah-based facility.

Co-Diagnostics began offering its COVID-19 test to some U.S. labs on March 2 as a result of the FDA’s policy for diagnostic tests for COVID-19 during the current public health emergency. Previously, the company had initiated sales of its CE-IVD test in Europe and to other global markets.

“We believe that this authorization confirms the quality and performance of our COVID-19 test, and that it is a significant step in opening more doors and helping this test to reach an even wider audience,” said Dwight Egan, CEO of Co-Diagnostics. “Many experts agree that accessibility of widespread testing is an important element to ‘flattening the curve’ as U.S. cases of COVID-19 continue to rise, and that increased testing throughput is vital to achieve this objective. We look forward to continuing our goal of increasing the availability of advanced, high-throughput and cost-effective COVID-19 testing solutions both close to home and across the globe.”