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Sunnyvale Company Cepheid Receives Approval From FDA for Rapid COVID-19 Test

A local molecular diagnostics company has received emergency approval from the U.S. Food & Drug Administration (FDA) to use one of its tests to detect SARS-CoV-2, the virus that causes COVID-19. The best part, results should be received within 45 minutes of taking the test.

Sunnyvale-based Cepheid says shipping of the tests will take place this week and the company expects to deliver millions of tests over the next few months and continue manufacturing efforts.

“This is the first on-demand test,” said Cammy Duong, of Canale Communications, a marketing company working with Cepheid.


Many hospital labs across the country already have Cepheid’s GeneXpert System within their lab. A doctor can take a sample from a patient, put it into the GeneXpert System and then find out in less than an hour if the patient tests positive for COVID-19.

“We call this ‘sample-to-answer’ and it can be achieved faster than any other test available,” said Duong. “It takes less than a minute to prepare the cartridge with the patient sample and approximately 45 minutes for GeneXpert to determine a result after a test cartridge is loaded onto the system…Tests can be run on-demand, 24/7.”

Duong says this is better than most of the other testing systems on the market right now because those require a group of samples to be collected before a test can be run. With Cepheid’s system, each test can be run as it comes in.

Dr. David Persing, the Chief Medical and Technology Officer at Cepheid says this method of testing will help hospitals battle the influx of patients.

“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. Persing.

“We are hoping it will have an impact on reducing spread and better managing hospital resources,” said Duong.

To create the SARS-CoV-2 test, Cepheid worked off a test that was already approved by the FDA. That test was used to detect the flu and Respiratory Syncytial Virus (RSV).

Cepheid was founded in 1996.


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