FDA greenlights first 45-minute, point-of-care coronavirus diagnostic test

Novel Coronavirus SARS-CoV-2
Cepheid said it plans to begin shipping its novel coronavirus point-of-care test this week and is concurrently pursuing its approval in Europe. (NIAID - Rocky Mountain Laboratories)

The FDA has authorized its first rapid, point-of-care diagnostic for the novel coronavirus—allowing physicians in hospitals, clinics and emergency rooms to test a sample for the disease in about 45 minutes.

Developed by Cepheid, the test is built to run on its automated GeneXpert hardware, with more than 23,000 tabletop systems installed worldwide and over 5,000 in the U.S., according to the company. 

"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 healthcare facilities,” Cepheid’s chief medical and technology officer, David Persing, said in a statement.

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“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.

Cepheid's GeneXpert Xpress
point-of-care system (Cepheid)

With the FDA's emergency use authorization in hand, the company said it plans to begin shipping the test this week and is concurrently pursuing its approval in Europe.

"Approval of Cepheid system for rapid point of care #COVID19 testing is key milestone," wrote former FDA Commissioner Scott Gottlieb in a tweet. "We need other point of care tests like swabs that give readable results. Testing and serology are key to complementing population based mitigation with case containment."

Its cartridge-based design, containing all necessary reagents, is similar to Cepheid’s previous diagnostics for influenza and respiratory syncytial virus and accepts nasopharyngeal swab samples as well as nasal aspirates and washes.

“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort," HHS Secretary Alex Azar said in an FDA statement. "With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them."

Additionally, by searching for multiple regions of the coronavirus’ genome, Persing said the test is designed to detect both current and future variants of the infection.

"Our automated systems do not require users to have specialty training to perform testing—they are capable of running 24/7, with many systems already doing so today," said Cepheid President Warren Kocmond.

Editor's note: This story was updated with comment from the FDA and HHS.

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