US Regulators Approve Roche’s New And Faster COVID-19 Test.

Swiss pharmaceutical giant Roche announced Friday it had received emergency approval from US regulators for a new and much faster test for diagnosing the deadly new coronavirus.

The US Food and Drug Administration (FDA) has given the green light to commercialise the SARS-CoV-2 Test to detect the virus that has sparked the global COVID-19 pandemic, Roche said in a statement.

The test can be run in high volumes on fully automated equipment, Roche said, suggesting it could provide more results far faster than other tests available.

“We are increasing the speed definitely by a factor of 10,” Thomas Schinecker, head of Roche’s diagnostics unit, said in an interview with Bloomberg News………..

The new Roche tests, which will also now be available in markets that accept the European CE-mark certification, are run on Roche’s widely available cobas 6800/8800 systems and can provide results within 3.5 hours, the company said.

In a 24-hour period, the largest machines can provide results on up to 4,128 tests, it said.