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Roche said on Friday that the U.S. Food and Drug Administration has issued emergency use authorization to test patients who show signs and symptoms of COVID-19 infection.
The test will detect the virus in nasopharyngeal and oropharyngeal swab samples from patients who meet the clinical and epidemiological criteria for testing, and can be used with Roche's fully automated Cobas 6800 and Cobas 8800 systems.
The Cobas COVID-19 test is a real-time, reverse transcriptase polymerase chain reaction test. The single-well, dual target assay includes specific detection of COVID-19 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes the novel coronavirus that has infected nearly 133,000 people worldwide. Almost 5,000 people have died from COVID-19.
Roche noted that negative results with the Cobas test does not preclude infection and such results must be combined with clinical observations, patient history, and epidemiological information.
"Over the last weeks, our emergency response teams have been working hard to bring this test to the patients," Roche Diagnostics CEO Thomas Schinecker said in a statement.
Roche said that upon the authorization it will have millions of tests each month for use on the two Cobas systems and is "going to the limits of our production capacity."
Aside from Roche, the U.S. Centers for Disease Control and Prevention, and New York state have received FDA EUA for COVID-19 tests. Hackensack Meridian Health was granted preliminary EUA for its coronavirus test.
This story first appeared in our sister publication, Genomeweb.
