FDA Approves New Faster Coronavirus Test by Roche
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Reports are coming in on the FDA’s approval of a new test for Covid-19 that has been developed by Roche.
“U.S. health regulators have approved a new coronavirus test that will speed up by tenfold the ability to test patients, helping solve a significant obstacle to American efforts to contain the virus.
The Food and Drug Administration granted “emergency use authorization” to the test, which runs on Roche Holding AG’s cobas 6800/8800 systems. The 8800 system is capable of testing 4,128 patients a day, and the 6800 version can test as many as 1,440. The tool also is available in Europe and countries that accept its CE marking for medical devices.”
“A new, high-speed coronavirus test has been granted emergency clearance by the Food and Drug Administration, the latest effort to expand capacity to diagnose the fast-spreading pathogen.
The test was developed by diagnostics giant Roche Holding AG and is designed to run on the company’s automated machines, which are already installed in more than 100 laboratories across the U.S. It will be available immediately.”
https://www.wsj.com/articles/fda-grants-new-coronavirus-test-emergency-approval-11584090078?mod=e2tw
“Medical diagnostics giant Roche (RHHBY) said it received “Emergency Use Authorization” to begin mass-producing coronavirus testing kits and also processing the results from the U.S. Food and Drug Administration.
The Geneva-based pharmaceutical company said the FDA has given it the go-ahead for what it formally called the cobas SARS-CoV-2 Test for the qualitative detection of SARS-CoV-2, the novel coronavirus”
https://www.thestreet.com/world/roche-coronavirus-test-kits-fda
“A new, high-speed coronavirus test has been granted emergency clearance by the Food and Drug Administration, the latest effort to expand capacity to diagnose the fast-spreading pathogen.
The test was developed by diagnostics giant Roche Holding AG and is designed to run on the company’s automated machines, which are already installed in more than 100 laboratories across the U.S.”
https://www.marketwatch.com/story/roche-coronavirus-test-gets-emergency-fda-approval-2020-03-13
