Coronavirus: FDA grants emergency approval for faster test

According to Swiss drugmaker Roche, the Food and Drug Administration has granted “emergency use authorization” for a highly automated coronavirus test, potentially speeding up the ability to test patients by a factor of 10. The test runs on Roche Holding AG’s cobas 6800/8800 systems (which was launched in 2014). The 8800 system is capable of testing 4,128 patients a day, and the 6800 version can test as many as 1,440.

This is the third coronavirus test, but the first commercially available one to be granted emergency approval by the FDA. It analyze nucleic acids extracted from patients’ saliva or mucus, and compare them against sequences found in coronavirus strains.

Roche’s cobas systems are widely available globally, with 695 of the 6800 instruments and 132 of the 8800 systems already installed. The US has 110 of these tools, and according to Roche, they installed a “significant amount” of new ones in key locations in the US in recent weeks. Roche declined to specify how many of those units are 8800 and how many are 6800 models. They also declined to comment on pricing for the tests.

With the United States and Europe being criticized for testing people too slowly for the coronavirus, this will help in getting things moving in the right direction. Testing will stem the spread of Covid-19 because it allows health care professionals to identify the infected and quarantine them. That can potentially reduce the overall number of infections thus allowing time for drugmakers to come up with better treatments and, ultimately, a vaccine.

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