Commercial Labs Step up Coronavirus Test Efforts After FDA Guidance

LabCorp’s test, called LabCorp 2019 Novel Coronavirus (COVID-19), NAA test, became available for ordering by physicians or other authorized healthcare providers in the US as of 6:00 PM ET. It will soon be joined by Quest Diagnostics, which said on Thursday that it plans to launch its SARS-CoV-2 test on March 9 to aid in the “presumptive detection of nucleic acid in respiratory specimens of patients” who meet the US Centers for Disease Control and Prevention’s criteria for testing. 

The LabCorp 2019 Novel Coronavirus (COVID-19), NAA test, along with those that will be offered by Quest and BioReference, are being made available pursuant to US Food and Drug Administration guidance issued on Feb. 29 that allows high-complexity, CLIA-certified labs to immediately perform tests they’ve developed and validated for the SARS-CoV2 coronavirus while they are pursuing Emergency Use Authorization.

Source: https://www.genomeweb.com/clinical-lab-management/commercial-labs-step-coronavirus-test-efforts-after-fda-guidance