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FDA Issues Emergency Use Authorization for Roche SARS-CoV-2 Test

NEW YORK – Roche said on Friday that the US Food and Drug Administration has issued Emergency Use Authorization for the Cobas SARS-CoV-2 Test.

The test, which is also CE-IVD marked, is for patients who show signs and symptoms of the disease COVID-19, caused by the SARS-C0V-2 coronavirus. It is for the qualitative detection of SARS-CoV-2 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 SARS-CoV-2 Test is a real-time, reverse transcriptase PCR test. The single-well, dual target assay includes specific detection of SARS-CoV-2 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 SARS-CoV-2 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. "CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease."

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 US Centers for Disease Control and Prevention, and New York state have received FDA EUA for SARS-CoV-2 tests. Hackensack Meridian Health CDI was granted preliminary EUA for its coronavirus test.