News and Commentary

FDA Greenlights Accelerated COVID-19 Test: ‘Results Within Hours Rather Than Days’
Nurse Canan Emcan shows a test kit for coronavirus samples at the isolation ward of the Uniklinikum Essen university hospital in Essen, western Germany, on March 9, 2020.
Photo by INA FASSBENDER/AFP via Getty Images

On Saturday, the Food and Drug Administration (FDA) issued a press release stating that the organization has greenlit a new test for COVID-19 from Cepheid that will provide results at a much faster rate than previous tests.

Secretary of Health and Human Services Alex Azar stated in the press release that the newly authorized test will significantly shorten the window of time between test and potential diagnosis:

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. 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.

FDA Commissioner Stephen Hahn, M.D. added that the organization has been working to “expedite” new diagnostic tools to aid in the fight against the coronavirus.

“Today marks an important step in expanding the availability of testing and, importantly, rapid results,” Hahn said. “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. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

In a March 20 letter to company Cepheid, the FDA wrote in part: “Emergency use of this [Xpert Xpress SARS-CoV-2] test is authorized to be distributed and used in patient care settings using the GeneXpert Xpress System.”

In addition to explaining the scope and detailing the laundry list of conditions under which the product may be used, FDA Chief Scientist RADM Denise M. Hinton wrote:

Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and …

There is no adequate, approved, and available alternative to the emergency use of your product.

In their own press release, Cepheid stated that their “test has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, with a detection time of approximately 45 minutes.” The release also noted that there are “nearly 5,000 GeneXpert Systems in the US capable of point-of-care testing and for use in hospitals.”

Coronavirus, which causes the illness COVID-19, originated in China’s Hubei province.

The virus has infected over 299,000 people worldwide, and led to more than 12,760 deaths, according to data from Johns Hopkins Center for Systems Science and Engineering (CSSE) Global Cases map.

Approximately 95,564 people who had COVID-19 have recovered.

In the United States, there have been more than 24,000 confirmed cases of the illness, and 285 deaths as of publication. 171 people have recovered.

New York, which has quickly become a COVID-19 hotspot in the U.S., has over 11,600 confirmed cases, according to the CSSE Global Cases data. That represents nearly half of all confirmed cases in the United States. As of publication, 56 people in New York have died from the illness.

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