WASHINGTON – The Food and Drug Administration late Friday approved the first coronavirus test that can be conducted entirely at the point of care for a patient – and deliver results in 45 minutes.
The FDA granted “emergency use authorization” to Cepheid, a California company that makes a rapid molecular test for the coronavirus. The turnaround time for Cepheid’s product is far shorter than for the tests being used, which are typically sent to centralized labs that may not return results for days.
The FDA authorization is for use in “patient care settings,” including doctors’ offices, but initially will be used primarily by hospitals and emergency departments, the company said.
As covid-19 cases proliferate, fears are growing that hospitals will become overwhelmed by patients seeking tests or care. David Persing, Cepheid’s chief medical and technology officer, said in an interview that the test will “help alleviate the pressure” on health-care facilities by helping doctors find out quickly whether a patient has the disease and select the appropriate treatment.
“This is not a test for the worried well,” he said, but rather a tool for doctors to quickly assess patients suspected of having covid-19.
The specimen can be collected either by a nasal swab or by a saline wash using a small catheter. Neither is particularly comfortable, but the advantage of the wash is that it doesn’t require swabs, which are in short supply, said Persing.
“We need alternative collection methods,” he added.
To further ease pressure on hospitals, the administration has said it is exploring at-home test kits. But so far, the FDA stressed on Friday, it has not approved any testing at home. It warned consumers to avoid “unauthorized, fraudulent” test kits.
William Jaquis, who is president of the American College of Emergency Physicians, said the newly authorized test will be “extremely helpful” by reducing delays in getting results.
The test, like the company’s existing strep and flu tests, does not require confirmatory tests, said Persing.
The coronavirus test is designed to operate on the company’s automated GeneXpert Systems. There are about 23,000 of those systems throughout the world, of which 5,000 are in the United States, according to the company.
The firm plans to begin selling the test at the end of the month. Persing declined to say how many tests initially will be produced but said the goal is to make millions in the next few months.