F.D.A. Approves New Coronavirus Test Under ‘Emergency Use Authorization’ By Zachary Evans
F.D.A. Approves New Coronavirus Test Under ‘Emergency Use Authorization’
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.
Members of Congress on both sides of the aisle have expressed frustration with the CDC over the lack of coronavirus tests currently available to Americans.
“We have a serious deficiency in being prepared for testing,” Senator Lamar Alexander (R., Tenn.) said on Thursday. “South Korea, for example, is doing a better job. We not only need a better system for later. We need a better system for now, and we’re going to focus on that as rapidly as we can.”
South Korea has been able to test about 15,000 people per day for the coronavirus, while government labs in the U.S. have only completed about 5,000 tests since the start of the outbreak.
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