FDA Approves Coronavirus Test That Can Provide Results In 45 Minutes

[mystery-ak]

Chuck Ross
Investigative Reporter
March 21, 2020 1:37 PM ET


The Food and Drug Administration (FDA) approved the use of a coronavirus test that can detect the virus within 45 minutes, the company that makes the tests announced on Saturday.

The FDA approved the test, created by Cepheid, a California-based medical device company, through Emergency Use Authorization, a process the helps circumvent the lengthy approval process for drugs, medical supplies and diagnostic measures.

Cepheid said that its “point-of-care” test is compatible with 23,000 automated systems it has in hospitals around the world. Five thousand of those are in the United States, the company said in a statement.

“We have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly,” Dr. David Persing, Chief Medical and Technology Officer at Cepheid, said in the statement.

“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.”

more
https://dailycaller.com/2020/03/21/fda-approves-cepheid-coronavirus-test-45-minutes/

[Elderberry]

https://www.breitbart.com/border/2020/03/21/rapid-coronavirus-test-approved-by-fda-results-in-45-minutes/

The company says it will begin shipping the tests next week.

“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” FDA Commissioner Stephen Hahn, M.D. concluded. “Today 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. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”