https://www.nationalreview.com/news/f-d-a-approves-new-coronavirus-test-under-emergency-use-authorization/?utm_source=recirc-desktop&utm_
The Food and Drug Administration on Friday approved the use of a Wuhan coronavirus diagnostic that will be able to test patients faster than any diagnostic currently available in the U.S.
Roche Holding AG, a Switzerland-based healthcare company, received “emergency use authorization” to roll out the test. The test can be run on two models of Roche’s diagnostic systems, with one model able to complete 1,440 tests per day and the second model 4,128 tests per day.
“We are increasing the speed definitely by a factor of 10,” said Thomas Schinecker, head of Roche’s diagnostics unit, in comments to Bloomberg News. “We definitely extended the capacity of the testing significantly throughout the U.S.”
The Roche test is just the third diagnostic given emergency approval by the FDA since the start of the outbreak. The other two tests approved were developed by the Center for Disease Control and Prevention and the New York State Department of Health, and the FDA has given separate approvals to hundreds of hospital laboratories to develop tests.