Aim of new service is to supplement public health response in the United States.
SECAUCUS, N.J. /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today 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, March 9, 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.
"In times of national health crises, quality laboratory testing is absolutely critical to mobilizing effective public health response," said Steve Rusckowski Chairman, CEO and President, Quest Diagnostics. "Quest's national scale, diagnostic expertise and innovation, and relationships with half the country's physicians and health systems is a vital complement to the efforts of the CDC and other public health labs to contend with a growing number of suspected COVID-19 cases in the United States. We applaud the FDA for providing the flexibility for innovative, quality lab developed tests to be brought to patients and providers quickly to advance effective response to the coronavirus outbreak."
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.
For more information about the company's response to COVID-19, visit www.questdiagnostics.com/home/Coronavirus/