Roche Gets Emergency Approval for First Fast Covid-19 Test -- Barrons.com
10:08 am ET March 13, 2020 (Dow Jones) Print
By Bill Alpert
The first high-speed coronavirus test was approved by the U.S. Food and Drug Administration, said Roche Holding today. The Swiss medical giant's new test works in its high-volume cobas 6800/8800 systems -- widely used diagnostic machines that will be able to process up to 4,000 of the Covid-19 tests per hour. That's 10 times faster than currently used tests.
There are more than 800 of the automated Roche systems around the world, the company has said, including about 110 in the U.S. More have been placed in recent weeks. Millions of units of the Roche test will be available for the hospital and commercial labs that use its system, the company said.
Diagnostic products like the new test account for 20% of the $62 billion in revenue reported in 2019 by the company. Roche stock (ticker: ROG.Switzerland) is up 8.5% today on the news, to 298 Swiss francs (U.S. $313).
"Over the last weeks, our emergency response teams have been working hard to bring this test to the patients," said the chief of Roche Diagnostics, Thomas Schinecker, in the company's announcement.
Approved under the FDA's "emergency use authorization," the Roche test is only the third test licensed in the U.S., coming after two slower diagnostics developed by the Centers for Disease Control and Prevention and by New York state.
Frustrated with the response speed of the U.S. federal government, states like New York have made their own arrangements with medical labs to handle testing for Covid-19. South Korea was hit early by the outbreak and has now performed more than 20 times as many tests than the U.S., despite having only 16% as many citizens.
Write to Bill Alpert at william.alpert@barrons.com
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