The Food and Drug Administration (FDA) has approved the first coronavirus diagnostic test that can be conducted entirely at the point of care.
The test from California-based Cepheid will deliver results in about 45 minutes — much faster than current tests that require a sample to be sent to a centralized lab, where results can take days.
The test has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S., the company said. The systems are already being used to test for conditions such as HIV and tuberculosis.
The systems do not require users to have specialty training to perform testing and are capable of running around the clock.
“An accurate test delivered close to the patient can be transformative” and can “help alleviate the pressure” that the COVID-19 outbreak has put on health facilities, David Persing, Cepheid’s chief medical and technology officer, said in a statement.
“People in general are frustrated with the turnaround time. They don’t know their status until days later. Knowing your status quickly … will allow much better decisionmaking” and help doctors choose the best treatment, Persing said in a video on the company’s website.
The test initially will be used primarily by hospitals, the company said, but the FDA’s “emergency use authorization” covers all “patient care settings,” including doctors’ offices.
The test will begin shipping next week.