The US Food and Drug Administration (FDA) has approved the first rapid coronavirus diagnostic test, with a detection time of about 45 minutes, the test’s developer, California-based molecular diagnostics company Cepheid, has said.
Cepheid said in a statement it had received an emergency use authorisation from the FDA for the test, which will be used primarily in hospitals and emergency rooms. The company plans to begin shipping it to hospitals next week, it said.
“During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid.
“An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” Persing added.
Under the current testing regime, samples must be sent to a centralised lab, where results can take days.