The Food and Drug Administration (FDA) has granted a new emergency authorization for a test for the new coronavirus, the latest move in attempts to quickly expand the availability of tests in the United States.
The test, developed by Switzerland-based Roche, is designed for use on two machines the company developed that are widely available across America. It’s only the third coronavirus test to receive an emergency use authorization from the FDA and the first that’s commercially distributed.
Roche’s test provides results in just three and a half hours. Running tests concurrently, its best system can analyze 4,128 results in 24 hours, the company said in an email to The Epoch Times.
“We are working around the clock to increase that quantity as we recognize the importance that patients need access to these critical tests,” it said.
The test kit allows hospitals and laboratories to perform tests. Millions of tests a month will be available for the institutions. The kit tests samples taken from the nose or throat.
“Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic. It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” Thomas Schinecker, CEO of Roche Diagnostics, said in a statement.
The FDA previously granted the authorization to the Centers for Disease Control and Prevention (CDC) but the test the agency developed didn’t always produce conclusive results, leading to a weekslong-delay in testing for the new virus. More recently, the FDA granted authorization for a test created by the New York State Department of Health.
Dr. Stephen Hahn, the FDA commissioner, said the agency approved Roche’s test within 24 hours of receiving the application.
“To expedite test access, FDA did not object to Roche pre-positioning its test so that labs could initiate testing immediately upon EUA authorization,” he said in a statement. “Because of pre-positioning, labs can run tests on Roche’s high-volume platform, which greatly increases national testing capacity.”
Over 60 developers have worked with the FDA on tests they plan on bringing through the emergency use authorization process, Hahn said.
Scott Gottlieb, a former FDA commissioner, said that the approval of Roche’s kit was “very significant.”
The test “will substantially increase patient testing capacity by end of next week by tens of thousands a day across all labs, commercial and academic,” he said in a statement.
While Roche’s systems are produced in Switzerland, the test is being produced in Branchburg, New Jersey, in the United States.
The FDA’s emergency use authorization allows companies to operate outside normal approval processes.
“It is reasonable to believe that the known and potential benefits of the authorized” test “outweigh the known and potential risks of such a product,” Denise Hinton, chief FDA scientist, said in a letter to Roche.
Other companies are also working on developing tests for the new virus while some, including Quest Diagnostics, already have, pending emergency use authorization.
Both tests may be able to detect the coronavirus, also known as SARS-CoV-2, in approximately one hour.
“Americans need access to rapid diagnostic testing. The sooner clinicians, patients, and public health officials know whether someone is infected with the novel coronavirus, the sooner they can take action to mitigate the spread of COVID-19,” said BARDA Director Rick Bright in a statement.
