FDA Authorizes New Quest Diagnostics Lab Method Designed to Increase COVID-19 Molecular Diagnostics Capacity


Technique to increase COVID-19 molecular diagnostic testing capacity and provide faster test results reporting

SECAUCUS, N.J.July 29, 2020 /PRNewswire/ — Quest Diagnostics (NYSE:DGX) today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for a new laboratory technique that speeds the process of extracting viral RNA from specimens* and will enable the company to expand its daily capacity of COVID-19 molecular diagnostic tests on behalf of patients in the United States.

“Laboratory innovation is key to optimizing testing capacity for COVID-19,” said Steve Rusckowski, Chairman, Chief Executive and President, Quest Diagnostics. “We appreciate the collaboration of the FDA to bring this technique to several of our labs spanning the U.S. With more testing capacity, we expect to improve turnaround times for our customers and patients.”

With the new FDA EUA, six of the company’s laboratories in the U.S. may now run this new RNA extraction method, including on pooled specimens. Those laboratories are well situated geographically to address high testing demand in states where the virus has been surging. The labs are in San Juan Capistrano and Valencia, CaliforniaLewisville, TexasLenexa, KansasChantilly, Virginia; and Marlborough, Massachusetts.

Omega Bio-tek’s Mag-Bind® Viral RNA Xpress Kit (M6219) is used in the viral RNA extraction step listed in Quest Diagnostic’s Emergency Use Authorization.

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