Quest Diagnostics to launch Coronavirus Disease 2019 (COVID-19) test

Quest Diagnostics the world's leading provider of diagnostic information services, announced it will launch a coronavirus (COVID-19) test service. The new test service aids the presumptive detection of nucleic acid in respiratory specimens of patients meeting CDC's clinical criteria for COVID-19 testing. Quest will be in position to receive specimens for testing, and begin to provide testing on Monday, 9 March 2020. With the new service, Quest Diagnostics will provide access to a COVID-19 test service for patients in the United States. 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. The service is going ahead pending an emergency use authorization (EUA) from the FDA..