FDA: Newly-approved coronavirus test works in 45 minutes, to be rolled out next week

A patient COVID-19 swab is taken out from a sterile tube as lab technicians carry out a diagnostic test for coronavirus in the microbiology laboratory inside the Specialist Virology Centre at the University Hospital of Wales in Cardiff. (Photo by Ben

The U.S. Food and Drug Administration has announced that it has approved the use of a rapid coronavirus diagnostic test that returns results in approximately 45 minutes.

Cepheid, a California-based molecular diagnostics company behind the test, says that it expects it to begin shipping next week. 

"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. 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," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid.

So far in New York, Governor Andrew Cuomo said the state has tested 45,437 people, more than any other state in the nation and more per capita than in China or South Korea. 10,356 people have tested positive for the virus, with 1,603 victims hospitalized. 

New Jersey has begun aggressively testing for the virus, with 1,327 positive coronavirus cases found in the state. Governor Phil Murphy said a drive-thru testing site in Bergen County has had to close on Friday and Saturday when it reached capacity after testing a few hundred residents. 

According to the CDC, as of March 20, 91 public health laboratories in every state in the nation are now offering testing for coronavirus. Up until late February, the CDC was doing the overwhelming majority of testing for the virus, but was largely only capable of testing a few dozen specimens each day. 

However, since more and more public health laboratories have joined the fight, since March 1, they have conducted 61,139 tests for coronavirus, compared to just 1,274 from the CDC in that same time period.

So far, according to the CDC, there are 15,219 cases of coronavirus in the United States, causing 201 deaths. The virus has been reported in all 50 states and four territories.

Globally, there are over 287,000 cases of coronavirus confirmed around the globe, with 11,900 deaths. Nearly 89,000 people have recovered. 


Get breaking news alerts in the FOX5NY News app. It is FREE!

Download for iOS or Android