Roche Receives Emergency Use FDA Approval for Automated Coronavirus Test

Roche Holding AG (Basel, Switzerland) has received the US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) for its cobas SARS-CoV-2 Test which is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease. Hospitals and reference laboratories can run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are widely available in the US and around the world. The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.

The cobas SARS-CoV-2 Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2. The test is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the CDC SARS-CoV-2 clinical criteria. Roche’s cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test results in three and half hours and offer improved operating efficiency, flexibility, and fastest time-to-results with the highest throughput providing up to 96 results in about three hours and a total of 384 results for the cobas 6800 System and 960 results for the cobas 8800 System in eight hours. The test can be run simultaneously with other assays provided by Roche for use on the cobas 6800/8800 Systems. Upon authorization Roche will have millions of tests a month available for use on the cobas 6800 and 8800 systems.

"Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic. It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” said Thomas Schinecker, CEO of Roche Diagnostics. “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 EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease.”

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