On Mar. 5, 2020, Quest Diagnostics announced it will launch a coronavirus (COVID-19) test service. The new test service was planned to aid the presumptive detection of nucleic acid in respiratory specimens of patients meeting Centers for Disease Control and Prevention’s (CDC) clinical criteria for COVID-19 testing.

The new test service will be provided as a laboratory developed test, pending review by the FDA under emergency use authorization (EUA) which the company will submit per FDA guidance within 15 days of clinical testing. The test is a molecular based assay which detects viral RNA in respiratory specimens.

The new service is expected to employ respiratory specimens collected in appropriate health care settings, such as hospitals and physician offices. Quest Diagnostics patient service centers and phlebotomy sites do not collect respiratory specimens on suspected COVID-19 cases. Patients suspected of, or confirmed to have, COVID-19 should consult with a physician regarding the best way to provide a specimen for testing by Quest. 

Coronavirus Disease 2019 or COVID-19 (formally known as 2019-nCoV) is the name for the respiratory syndrome caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Quest Diagnostics is a leader in infectious disease testing services, with a broad menu of molecular, antibody, and other test services to aid diagnosis, treatment and monitoring.