Days after a Swiss drug and diagnostics maker received a special authorization from the Food and Drug Administration for its coronavirus test, the agency has given a similar nod to another company.
Waltham, Massachusetts-based Thermo Fisher Scientific said Monday that it had received an emergency use authorization, or EUA, from the FDA for its diagnostic test to detect the Covid-19 virus on Friday. The test uses Applied Biosystems TaqPath Assay technology and is designed to provide results within four hours.
Thermo Fisher’s shares were down 6.9% on the New York Stock Exchange Monday afternoon amid a widespread plunge in stocks generally that prompted a trading halt in the morning.
“The authorization of our diagnostic test for Covid-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” Thermo Fisher CEO Marc Casper said in a statement. “At Thermo Fisher, our mission is to enable our customers to make the world healthier, cleaner and safer.”
Basel, Switzerland-based Roche said Friday that the FDA had granted an EUA to its diagnostic, designed to run on the company’s Cobas 6800 and 8800 lab-testing systems. An EUA is not an approval, but allows for temporary use of a diagnostic, drug or vaccine when the Department of Health and Human Services declares a public health emergency.
According to media reports, HHS assistant secretary for health Brett Giroir said in a briefing at the White House briefing that 2,000 commercial labs would start performing coronavirus tests, with up to 1.9 million tests available by the end of the week. Still, The New York Times reported, some experts remain skeptical as to whether the government can meet that goal.
The news comes amid widespread criticism of a lag in testing for the virus, with reports that the U.S. has performed as many tests in the year to date as South Korea performs on a given day, allowing the virus to spread unchecked around the country.
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