Co-Diagnostics Gets EUA From FDA For Logix Smart COVID-19 Test - Quick Facts

(RTTNews) - Molecular diagnostics company Co-Diagnostics, Inc. (CODX) announced Monday that its Logix Smart coronavirus COVID-19 test has obtained Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2.

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 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.