Coronavirus Pandemic: Sunnyvale Firm Receives FDA Emergency Approval For Rapid COVID-19 Test
SUNNYVALE (CBS SF) -- A rapid test to detect the coronavirus, developed by Cepheid -- a Sunnyvale company, has been given "emergency use authorization" by Food and Drug Administration, officials said Saturday.
The company said it received FDA approval late Friday night to deploy its test -- designed to operate on the company's automated GeneXpert Systems -- that can get results in 45 minutes in a hospital laboratory.
The test will begin being shipped to hospital next week.
"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," said Dr. David Persing, Chief Medical and Technology Officer at Cepheid in a news release. "We have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly."
There are about 23,000 of those systems throughout the world, of which 5,000 are in the United States, according to the company.
The FDA authorization covers patient care settings including doctors' offices, but initially will be used primarily by hospitals and emergency departments, the company said.
Unlike current tests, the Cepheid test does not require a nasal swab; nasal aspirate can be used. Officials said the CDC rules on who can be tested will still apply.
Officials were also imploring people who don't really need tests, to refrain from getting one.
"In a universe where masks and gowns are starting to become scarce, every time we test someone who doesn't need one, we're taking that mask and gown away from someone in the intensive care unit," said Demetre Daskalakis, deputy commissioner for the Division of Disease Control of the New York City Department of Health and Mental Hygiene.
Vice President Mike Pence announced at a press briefing Saturday that more than 195,000 have been tested in the United States for the virus. Of those, there have been 19,344 confirmed cases.
There have 530 confirmed cases in the 10 San Francisco Bay Area counties. Napa County has not had a confirmed case while there have been 196 in Santa Clara County.
