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March 16, 2020

FDA issues emergency use authorisation for Roche coronavirus test

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Roche’s Cobas SARS-CoV-2 Test to detect the virus that causes the coronavirus (Covid-19).

Follow the latest updates of the outbreak on our timeline.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Roche’s Cobas SARS-CoV-2 Test to detect the virus that causes the coronavirus (Covid-19).

The test is for the qualitative detection of the virus SARS-CoV-2 in nasopharyngeal or oropharyngeal swab samples from patients who meet Covid-19 clinical or epidemiological testing criteria.

Roche is also offering the CE-IVD test in markets accepting CE mark approval. The test is for patients with Covid-19 symptoms and for those who live in affected areas.

The FDA’s EUA enables hospitals and reference laboratories to run the test on Roche’s fully automated Cobas 6800 and Cobas 8800 Systems to meet the urgent medical needs.

Roche Diagnostics CEO Thomas Schinecker said: “Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterised as a pandemic.  It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2.

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“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.”

Roche’s Cobas systems provide test results in three and a half hours. They also offer improved operating efficiency, flexibility, and fastest time-to-results.

The highest throughput provides up to 96 results in approximately three hours, a total of 384 results for the Cobas 6800 System, and 960 results for the Cobas 8800 System in eight hours.

The Cobas SARS-CoV-2 test is awaiting FDA clearance and approval.

Roche recently secured the FDA approval for its CINtec PLUS Cytology test that provides additional information for HPV-positive women at risk of developing cervical cancer.

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