FDA gives emergency authorisation to first coronavirus tests
pharmafile | March 17, 2020 | News story | Manufacturing and Production, Sales and Marketing | FDA, Roche, US, coronavirus
The coronavirus crisis in the US has thus far been characterised by a lack of testing within its population. This situation has evolved due to a number of factors, from a lack of testing kits across the country to a reluctance on the part of the US Federal Government to encourage widespread testing.
The FDA has stepped up to remedy this problem by awarding Emergency Use Authorization to Roche’s cobas SARS-CoV-2 Test for the COVID-19 coronavirus, making it the first commercial test approved in the US for the disease.
According to the US regulator, hospitals and reference labs will be able to utilise the test by running it on Roche’s cobas 6800 and 8800 systems which are widely available throughout the country. Using these platforms, test results can be generated within three and a half hours; over an eight hour period, 384 test results could be generated with the 6800 system and 960 results with the 8800 system.
“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,” 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.”
Matt Fellows
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