Roche receives emergency FDA approval for coronavirus test

Roche test kit for SARS-CoV-2, which causes the COVID-19 disease. (Courtesy Roche)

INDIANAPOLIS (WTHR) - Roche announced Friday that its has received emergency approval from the U.S. Food and Drug Administration (FDA) for diagnostic test that will detect COVID-19.

In an announcement shared with WTHR, the "reliable and accurate test for SARS-CoV-2 will enable expedited coronavirus testing to meet urgent medical needs" and "will significantly increase available testing capacity."

The test is intended to detect SARS-CoV-2, the virus that causes COVID-19 disease when swab samples are taken from patients who meet the clinical criteria of the Centers for Disease Control and Prevention (CDC). Hospitals and labs can then run the samples on Roche’s fully automated cobas 6800 and 8800 systems, which are widely available in the U.S. and around the world.

Results come back in three and a half hours, Roche said.

Thomas Schinecker, CEO of Roche Diagnostics, said in the release, “Over the last weeks, our emergency response teams have been working hard to bring this test to the patients. CE-mark certification and the FDA’s granting of (emergency approval) supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease.”

Roche said its test can return between 1,440 and 4,128 results in 24 hours, depending on which cobas system is used.

Upon approval, Roche said it can have millions of tests per month available to use on the cobas systems, and will push the limits of its production capacity during the pandemic.