The Food and Drug Administration granted emergency approval for a coronavirus test that could speed up diagnostics tenfold.
The FDA granted “emergency use authorization” to a diagnostic test made by Roche Holding AG that will be made available immediately. The test is run on two of the company’s diagnostic machines, which are already installed in more than 100 labs across the country. The company’s machines are capable of running about 5,000 tests per day.
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“We are increasing the speed definitely by a factor of 10,” Thomas Schinecker, the head of Roche’s diagnostics unit, told Bloomberg News.
This will be the third test to be granted emergency use authority by the FDA since the coronavirus outbreak began. Until now, only one from the Centers for Disease Control and Prevention and one from the New York State Department of Health have been authorized.
The process of diagnosing and reporting coronavirus cases in the United States has been marred by inaccurate tests only available through the CDC until about two weeks ago. Meanwhile, China, Italy, and the United Kingdom can test tens of thousands of people for the coronavirus, according to the World Health Organization.
Roche’s two machines, the cobas 6800/8800, can provide test results within four hours. According to Bloomberg News, the company is installing “a significant amount” in more key locations.
The FDA’s Friday announcement comes on the heels of top infectious disease expert Anthony Fauci’s admission Thursday that test rollout has been flawed from the start.
“The system does not — is not really geared to what we need right now — what you are asking for. That is a failing. It is a failing. Let’s admit it,” Fauci told members of the House Oversight Committee on Thursday.
So far, in the U.S., more than 1,700 people have been infected with the coronavirus, and at least 39 people have died.
