U.S. Approves More ‘Rapid’ COVID-19 Tests For Use On Frontlines

The U.S. Food and Drug Administration is approving more rapid molecular diagnostic tests that can be used in temporary screening locations, doctor’s office labs and nursing homes to detect the Coronavirus strain COVID-19 within a half hour.

Mesa Biotech Tuesday morning said it received an “emergency use authorization” from the FDA for its Accula SARS-CoV-2 Test, which the company said provides “diagnostic results in 30 minutes.” It follows word from California-based Cepheid Saturday said that it received an “emergency use authorization” from the FDA for its Xpert Xpress SARS-CoV-2 test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.

The emergency use authorization for San Diego-based Mesa Biotech for the latest “rapid” test follows a parade of diagnostic test approvals for Coronavirus following weeks of criticism of the Trump administration and federal agencies for the lack of testing for Coronavirus. The U.S. is considered well behind other countries when it comes to the availability of testing generally.

But executives at Mesa Biotech, which is privately held, say their testing platform will help expand testing, particularly at the point of care including “temporary screening facilities, physician office labs, urgent care, and long term nursing facilities.”

“Our Accula system is easy to use and fits in the palm of your hand,” Mesa Biotech co-founder and chief executive Hong Cai said. “This allows many units to be run side by side in the doctor’s office further increasing the speed of COVID-19 diagnosis.”

Prior to FDA approval of the rapid tests, many of the Coronavirus tests recently approved earlier this month are used in large hospitals and academic medical centers.

“Our test will provide a highly accessible means for healthcare professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat or dismiss potential carriers of the virus,” Cai said. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”