Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test
SUNNYVALE, Calif., March 21, 2020
/PRNewswire/ —
Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA)
for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.
The 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.
Mar 21, 2020
Coronavirus: FDA Approves Point-Of-Care Diagnostic Test
Cepheid said the test kits will be available by the end of the month.
Until now,
to get test result,
a health care worker would take a swab from the back of a person’s nose, and
send it off to a public health, commercial or hospital lab, or to a lab at the Centers for Disease Control and Prevention in Atlanta.
The process can take days.
The newly approved test kit
still involves taking a nasal swab, but the test can be done in a doctor’s office or clinic with a detection time of approximately 45 minutes,
according to Cepheid.
Coronavirus Live Updates : NPR
FDA approves coronavirus test that can diagnose COVID-19 in 45 minutes
The US FDA on Saturday approved a new rapid coronavirus test by California-based Cepheid.
The test can detect the novel coronavirus within 45 minutes, and can be processed by providers without training on one of the company’s 5,000 machines across the country.
On March 13, the FDA also gave emergency clearance for a test by Roche, which can diagnose COVID-19 in about three hours. Previously, patients have had to wait days for a diagnosis.
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