Quest Diagnostics, Secaucus, NJ, a leading provider of diagnostic information services, has announced that it will launch a coronavirus (COVID-19) test service. The new test service aids in the presumptive detection of nucleic acid in respiratory specimens from patients meeting the clinical criteria for COVID-19 testing established by the US Centers for Disease Control and Prevention (CDC).
Quest will be in position to begin receiving specimens on Monday, March 9, and will then begin to provide testing. With the new service, Quest Diagnostics will provide access to a COVID-19 test service for patients in the United States. The test is a molecular-based assay that detects viral RNA in respiratory specimens.
The new test service will be provided as a laboratory-developed test, pending FDA review for an emergency use authorization (EUA), for which the company will submit a request per FDA guidance within 15 days of clinical testing.
“In times of national health crises, quality laboratory testing is absolutely critical to mobilizing effective public health response,” says Steve Rusckowski, chairman, CEO, and president of 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 CDC and other public health labs to contend with a growing number of suspected COVID-19 cases in the United States. We applaud 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.”
For further information, visit Quest Diagnostics.
