FDA approves automated coronavirus test
The U.S. Food and Drug Administration has granted diagnostics company Roche emergency approval to start selling a high-speed coronavirus test. The green light from regulators comes amid concerns that difficulty screening large segments of the U.S. population has allowed the virus to spread.
The test, designed to run on a computerized diagnostic system developed by Roche, will be available immediately and can be run on machines already in place at more than 100 laboratories across the U.S., according to Roche, based in Basel, Switzerland. One version of the device can test more than 4,000 patients a day, while a second can perform nearly 1,500 tests, the company announced.
“Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic,” Roche CEO Thomas Schinecker said in a statement.
The test — the first to be commercially available — is the third coronavirus diagnostic tool to get emergency clearance from the FDA. The other tests were developed by the U.S. Centers for Disease Control and Prevention and by the New York State Department of Health.
The FDA is trying to quicken the pace of coronavirus testing after a difficult start in the U.S., with the CDC the only authorized entity to conduct tests up until two weeks ago. Furthering the trouble, some of the CDC’s tests proved to be inaccurate, a glitch the agency has since fixed.
“These actions today show our commitment to working around the clock to help expedite the availability of tests, FDA Commissioner Stephen Hahn, said in a statement on Friday.
The U.S. and much of Europe has come under fire for testing people too slowly and letting the virus spread. Roche’s systems were first introduced in 2014 and are widely available around the world, with more than 800 already installed in labs.