Quest: FDA Authorization Could Raise Daily Test Capacity by 35000

The US Food and Drug Administration (FDA) has authorized a technique which is intended to increase SARS-CoV-2/COVID-19 testing capacity and provide faster results, including on pooled samples.

The authorization was granted to the nationwide laboratory company Quest Diagnostics.

The laboratory technique accelerates extraction of viral RNA and the company hopes the authorization will expand its daily capacity of COVID-19 molecular diagnostic tests.

The method extracts RNA with the Mag-Bind Viral RNA Xpress Kit and the Hamilton MagEx STAR.

• The Mag-Bind test allows technicians to “isolate viral DNA & RNA from whole blood, serum, plasma & bodily fluids using magnetic beads” according to the manufacturer, Omega Bio-Tek.

• The MagEx STAR and related products are described by Hamilton Company as “fully automated solutions for magnetic bead-based nucleic acid extraction and is ideal for isolation of pathogen RNA from coronavirus...and can process up to 96 samples at a time.”

The authorization is expected to help Quest add an additional 35,000 tests daily in 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.

FDA has issued several other emergency use authorizations to diagnostics in recent days to address concerns with the speed and quality of testing in the United States:

• Quest was also granted authorization for COVID-19 specimen pooling last week.

• The first ever COVID-19 diagnostic test approved for everyone regardless of risk was authorized to LabCorp on July 26.

"Laboratory innovation is key to optimizing testing capacity for COVID-19," said Steve Rusckowski, Chairman, Chief Executive and President of Quest Diagnostics in the company’s announcement. "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."

As a result of the emergency use authorization, 5 of Quest’s laboratories may now run the testing method.

According to the announcement, the authorized labs are in ideal locations for COVID-19 testing in the United States: “San Juan Capistrano and Valencia, California; Lewisville, Texas; Lenexa, Kansas; Chantilly, Virginia; and Marlborough, Massachusetts.”

Quest also outlined a loose trajectory for testing expansion based on the authorization.

• 150,000 tests per day by next week.

• 185,000 tests per day by Labor Day.

• Average turnaround times of 1 day for priority patients and 2-3 days for all other patients in coming weeks.