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Quest Receives FDA EUA for Faster Viral RNA Extraction Method

NEW YORK – Quest Diagnostics said Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for a technique that speeds the extraction of viral RNA from patient samples.

The Secaucus, New Jersey-based company said it believes the technique, which it plans to run at six of its facilities, will let it expand its molecular SARS-CoV-2 testing capacity. Quest can currently run 135,000 molecular SARS-CoV-2 tests per day and expects the new method to boost that figure by 35,000 tests per day.

The new extraction method will be used at Quest's labs in San Juan Capistrano and Valencia, California; Lewisville, Texas; Lenexa, Kansas; Chantilly, Virginia; and Marlborough, Massachusetts.  

The company said it expects this expansion in capacity will allow it to bring test turnaround times down to one day for priority patients and two to three days for all other patients.

The new extraction method may be used with the Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real Time RT-PCR test. Quest noted that the technique is also compatible with pooled testing. The company received EUA for its pooled testing method on July 17.

"Laboratory innovation is key to optimizing testing capacity for COVID-19," Steve Rusckowski, Quest's chairman, CEO, and president, said in a statement. "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."