Sunnyvale company's COVID test awarded fast track approval

Wednesday, the production wheels were rolling at pharmaceutical company Cepheid. This, after the U.S. Food and Drug Administration awarded fast-track approval for the first test to detect the COVID-19 virus, and three other viruses.

“It’ll be a really important to bring to the front lines during the upcoming respiratory season,” said Cepheid Chief Medical & Technology Officer Dr. David Persing.

He and a team of 10 at the Sunnyvale-based company saw the coming flu season, and spent three months developing a four-plex test. One molecular testing method targeting RNA, to diagnose Covid, two forms of the seasonal flu-bug, and Respiratory Syncytial Virus, or RSV.

“The very young and the very old can get very ill with respiratory syncytial virus. Very COVID-like. They get all the classical symptoms that are very similar to covid. So it’s important to include that for those two segments of the population,” said Persing.

Persing says the new test is administered similar to existing COVID tests – by nasal cavity swabs. Those suffering symptoms can know results in a little more than a half hour, with 98% accuracy.

“I think that the development of this test will definitely make things a lot easier,” said Dr. Jake Scott, a Stanford University infectious diseases expert. “Come flu season, I can’t ever imagine anyone coming into an ER and not being tested for all three of those organisms...combining them will certainly help in terms of saving resources. Using one cartridge to test for all four.”

Cepheid officials say the new test are being shipped to hospitals and clinics in the Bay Area and beyond, arriving before the start of flu season in November. The next hurdle is making sure it’s compatible with various testing systems already in use.