FDA approves new coronavirus test that can diagnose within hours
New test kits may be ready by March 30.
The Food and Drug Administration announced approval Saturday for a new coronavirus test that can diagnose patients within hours, instead of days.
The new rapid test, manufactured by California-based Cepheid, is expected to be in the market by March 30, officials said.
“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests," Health and Human Services Secretary Alex Azar said. “With the development of point of care diagnostics, Americans who need tests will be able to get results faster than ever before. More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace, thanks to the hard work of our FDA team and the ingenuity of American industry.”
FDA Commissioner Stephen Hahn said the approval "marks an important step in expanding the availability of testing and, importantly, rapid results."
Hahn said because the rapid test can be administered at the point of care, it "means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory."