Roche receives FDA emergency use authorisation for Covid-19 diagnostic test

Roche’s cobas SARS-CoV-2 test has received an emergency use authorisation approval from the US Food and Drug Administration (FDA) to test patients showing signs and symptoms of Covid-19 disease.

The test is designed for the qualitative detection of SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical criteria for testing.

Roche said that the cobas SARS-CoV-2 Test can be performed on its cobas 6800 and 8800 lab-testing systems, which deliver results in three and half hours. 

The cobas SARS-CoV-2 test is a single-well dual target assay, which includes both specific detection of Covid-19 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes novel coronavirus.

CE-IVD test also available in markets that accept CE-mark certification

Roche stated that the new CE-IVD test will also be available in markets that accept the European CE-mark certification.

In just 24 hours, the cobas 8800 system can provide 4,128 results while the cobas 6800 system can deliver a combined 1,440 results.

Roche Diagnostics CEO Thomas Schinecker said: “Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organisation has characterised as a pandemic.

“It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2.

“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.”

According to the company, the test has been approved only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection.

Meanwhile, deaths from coronavirus infection have crossed 6,500 worldwide, with a total of more than 169,300 cases and 77,200 recoveries, as of the end of 15 March.

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