Co-Diagnostics has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Logix Smart coronavirus COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test for detecting SARS-CoV-2.
Clinical laboratories certified under CLIA can now use the test to detect the novel coronavirus that causes the respiratory disease COVID-19. The company said it began offering the product to CLIA labs last month, following the FDA's relaxation of regulations on testing, which paved the way for use prior to an EUA. The test had previously received the CE Mark in Europe.
