FDA approves coronavirus test with 45-minute turnaround
Washington – The U.S. Food and Drug Administration has approved a test that could detect coronavirus in patients in about 45 minutes, according to the developer of the units.
The device is made by Cepheid, a California-based company, which said units would be ready to be shipped next week.
The move could make it easier for health care workers to treat patients and aid in the correct allocation of resources, amid a trying time for hospitals.
Fast testing is seen as a key part of efforts to limit the spread of the new coronavirus.
The move would be part of a wider effort by the federal and state governments and the private sector to rapidly ramp up testing capacities. Other companies say they plan to roll out millions more test units.
The 45-minute test works on Cepheid’s proprietary system, the company said, noting there are some 23,000 worldwide. This could limit where the units can be used.
The FDA issued an emergency authorization for the device, amid a severe shortage of test kits in the US. Governors and health care workers in many states are saying they cannot do enough tests.
“Point-of-care testing 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,” said FDA Commissioner Stephen Hahn.
Health Secretary Alex Azar said the tests would provide “results within hours, rather than days like the existing tests.”