US regulators approve Roche's new and faster COVID-19 test
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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.
Widespread testing is essential in the race to rein in the spread of the virus, which has so far infected more than 130,000 people and killed nearly 5,000 worldwide.
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.
"It is important to quickly and reliably detect whether a patient is infected" with the virus," Schinecker said in the statement, insisting that speeding up the process of providing reliable diagnostics was "crucial to combat this serious disease."
Roche said it would have millions of tests available each month, and that it was committed to pushing the limits of its production capacity and delivering as many tests as possible.
© 2020 AFP