Thursday, 30 November, 2023
HomeCoronavirus WatchFDA issues emergency authorisation for Roche's faster coronavirus test

FDA issues emergency authorisation for Roche's faster coronavirus test

The US Food and Drug Administration (FDA) has issued emergency authorisation for a faster coronavirus test made by Swiss diagnostics maker Roche, a move aimed at boosting screening capacity to help contain the growing epidemic. Reuters Health reports that the new tests provide results in 3.5 hours and can produce up to 4,128 results daily. The Basel-based company said this was a boost to tests the company has offered until now.

The FDA’s Emergency Use Authorisation clears the tests to be deployed in the US and markets accepting the CE mark showing they conform to European standards.

The report says US testing was hampered by flawed kits distributed by the federal government in February, which gave some false results. That set the country back in containing an outbreak that has infected more than 122,000 people worldwide and more than 1,660 in the US. Roche said it is “going to the limits of our production capacity” to deliver as many of the faster tests as possible.

The report says the tests are for two diagnostics systems: Roche’s cobas 6800, which can process 1,440 samples per day, and its faster cobas 8800 that can do more than 4,100. Worldwide, there are 695 cobas 6800 systems installed and 132 of the 8800s, with “more than 100” in the US, Roche said.

[link url=""]Full Reuters Health report[/link]

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