Moderator: Irene Aihie April 22, 2020 12:15 pm ET Coordinator: Welcome and thank you for standing by. At this time all parties are in a listen-only mode until the question and answer segment of todays conference at which time you may press

South Korean molecular diagnostics firm Seegene announced after the close of the market on Tuesday that the US Food and Drug Administration has granted Emergency Use Authorization for the firms Allplex 2019-nCoV Assay, a real-time RT-PCR te

The US Food and Drug Administration on Friday granted Emergency Use Authorization to the Rutgers Clinical Genomics Laboratory for a SARS-CoV-2 test originally developed by Thermo Fisher Scientific that is modified for use on additional spec

The US Food and Drug Administration on Friday granted Emergency Use Authorization to the Rutgers Clinical Genomics Laboratory for a SARS-CoV-2 test originally developed by Thermo Fisher Scientific that is modified for use on additional spec

The US Food and Drug Administration on Monday granted Emergency Use Authorization to two lab-developed real-time RT-PCR tests for SARS-CoV-2, the virus that causes coronavirus disease COVID-19. The authorized tests are performed at Knoxvill

FDA is upping its response to address the novel coronavirus outbreak. The policy is aimed at laboratories seeking to develop diagnostic tests for the coronavirus. The policy allows laboratories to develop and begin to use the diagnostics be

NEW YORK The US Food and Drug Administration on Friday granted Emergency Use Authorization to Luminex for the firms NxTag CoV Extended Panel to detect SARS-CoV-2 virus nucleic acids in nasopharyngeal swab specimens. High-complexity molecula

NEW YORK Avellino Labs on March 25 received Emergency Use Authorization for its coronavirus real-time PCR diagnostic test from the US Food and Drug Administration. The assay, called AvellinoCoV2 test, is designed for the detection of nuclei

On March 23, 2020, FDA announced that on March 18, FDA and the European Medicines Agency (EMA) co-chaired the first global regulators meeting to discuss regulatory strategies to streamline vaccine development for SARS-CoV-2, which causes th

NEW YORK The US Food and Drug Administration on Friday warned consumers to watch out for companies marketing unproven products for diagnosing, preventing, or treating COVID-19. We will continue to aggressively pursue those who place the pub