FDA authorizes new coronavirus test that can deliver results in 45 minutes

It has become clear in the midst of the coronavirus pandemic that in a time of crisis, bloated bureaucracies with mountains of regulations can be more of a hindrance than a help. But as cases of COVID-19 continue to mount in the U.S. the Trump administration is cutting through the red tape.

According to The Hill, the U.S. Food and Drug Administration (FDA) moved quickly last week to authorize the use of a new coronavirus test that allows for patients to receive results in as little as 45 minutes.

The test “can be conducted entirely at the point of care,” according to The Hill, and delivers results much faster than previous tests, which often took days to process.

A new coronavirus test

Called SAR-CoV-2 Xpert Xpress, the new COVID-19 test was created by a California-based company called Cepheid, according to CNBC. The test is designed to work on the company’s pre-existing GeneXpert Systems, which are already in use to test for diseases like HIV and tuberculosis, The Hill notes.

At least 23,000 of the automated systems are currently in operation worldwide, including 5,000 in the U.S., The Hill reports.

The systems are reportedly designed to simple to operate, meaning users don’t need any sort of specialized training to work them. They are also capable of running continuously, The Hill notes.

A big step forward

Cepheid’s chief medical and technology officer David Pershing said in a statement that he hopes the tests will “help alleviate the pressure” currently placed on health care facilities across the U.S. by the ongoing COVID-19 outbreak.

“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,” Pershing said, according to CNBC. “An accurate test delivered close to the patient can be transformative.”

Trump administration officials have also touted the approval of the new tests, which U.S. Department of Health and Human Services (HHS) Secretary Alex Azar said “will be much more easily accessible to Americans who need them,” according to CNBC.

FDA Commissioner Stephen Hahn, meanwhile, said that approving the new diagnostic measures “marks an important step in expanding the availability of testing and, importantly, rapid results.”

“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,” Hahn added, according to CNBC.

CNBC reports that the tests from Cepheid “will begin to ship on Friday, March 27 with plans to roll it out by Monday, March 30” — and not a moment too soon.

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