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New Quest lab method gains FDA nod

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Quest Diagnostics (NYSE:DGX) announced that it received FDA emergency use authorization (EUA) for a new laboratory technique for extracting viral RNA.

Secaucus, N.J.-based Quest Diagnostics’ new technique is designed to speed up the process of extracting viral RNA from specimens in an effort to expand daily capacity of COVID-19 molecular diagnostic tests in the U.S., according to a news release.

Currently, Quest has the capacity to perform 135,000 COVID-19 molecular diagnostic tests per day, but the new method is expected to add an additional 35,000 tests per day over the next several weeks, with specimen pooling set to increase capacity even more.

As a result, the company anticipates the ability to perform 150,000 tests per day by next week and hopes to reach 185,000 per day by Sept. 7. Quest expects average turnaround times of one day for “priority 1” patients and between two and three days for all other patients in the coming weeks.

The company currently has the capacity to perform 135,000 COVID-19 molecular diagnostic tests a day. The new method is expected to add an additional 35,000 tests a day in overall capacity over the next several weeks. In addition, the company will be able to use specimen pooling with the new method to increase capacity even further.

Garnering EUA allows five of Quest’s laboratories to run the new RNA extraction method, including on pooled specimens. The labs are located in San Juan Capistrano and Valencia, California; Lewisville, Texas; Lenexa, Kansas; Chantilly, Virginia; and Marlborough, Massachusetts.

“Laboratory innovation is key to optimizing testing capacity for COVID-19,” Quest Diagnostics chairman, president & CEO Steve Rusckowski said in the release. “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.”

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