Co-Diagnostics, Inc Receives FDA Emergency Use Authorization for COVID-19 Test


Co-Diagnostics, Inc. , a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced that its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the FDA to be used for the diagnosis of SARS-CoV-2. The Company’s test can be used by clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) to detect the presence of the virus that causes COVID-19, and is available for purchase from the Company’s Utah-based ISO-13485:2016 certified facility.

Co-Diagnostics began offering its COVID-19 test to some U.S. CLIA labs in March 2020 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 to the European Community, and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration.

CEO of Co-Diagnostics Dwight Egan commented, “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. 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.”

The Co-Diagnostics Logix Smart™ Coronavirus COVID-19 Test uses the Company’s patented CoPrimer™ technology to target the RdRp gene of the SARS-CoV-2 virus. The advanced nature of CoPrimers has allowed Co-Diagnostics to design a highly-specific, single-well PCR test, allowing higher throughput over tests that require multiple wells. Co-Diagnostics believes the lower cost of reagents in the Company’s single-well test will help hospitals and laboratories to process more while paying less, benefiting healthcare providers and patients alike.

About Co-Diagnostics, Inc.:

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. The Company’s technology is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.