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FDA Gives Roche’s COVID-19 Test Emergency Clearance

March 16, 2020
The tests will reportedly allow hospitals to test more than 4,000 people a day.

This article has been updated.

On March 13, the Food and Drug Administration granted Roche AG an emergency use authorization for its SARS-CoV-2 commercial test system. Roche, a Swiss diagnostics and pharmaceuticals company, says the tests use their Cobas 6800/8800 diagnostic systems to detect the virus which causes COVID-19. The testing systems can provide results in three and a half hours, according to Roche.

Roche Diagnostics CEO Thomas Schinecker praised the FDA’s move. In a statement, Schinecker said “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.” The company said that “millions of tests a month” would be available upon authorization.

The test, which uses throat and nasal swabs to detect the virus, can detect other viruses in the same family as the one which causes COVID-19 but is under the EUA only authorized to be used to detect one.

The emergency authorization arrives as the United States faces conflicting information on the availability of tests for the virus, which the World Health Organization has labelled a pandemic. According to Roche, the global install base for the Cobas 6800 and 8800 systems are 695 units and 132 units, respectively. In one eight-hour span, the 6800 system can provide a total of 384 results while the 8800 system can run 960 results.

At a press conference given March 16, Director General of WHO Tedros Adhanom Ghebreyesys emphasized the importance of deploying tests for the virus. "We have a simple message to all countries—test, test, test,” said Ghebreyesus. Affected countries “cannot fight this pandemic blindfolded,” he said.

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