Sunnyvale based Cepheid continues to ramp up the production of its rapid COVID-19 test. Almost two months since receiving emergency approval for its test from the FDA, production has increased dramatically.
“Cepheid shipped more than 1 million SARS-CoV-2 test cartridges to over 800 customers in all 50 states in the first month since receiving [Emergency Use Authorization] EUA from the [Food and Drug Administration] FDA on March 21, 2020,” said a Cepheid spokesperson. “We have shipped 2 million tests cartridges so far and expect to ship 6 million per quarter to 900 locations in all 50 states in the US. Demand is still high and more tests are needed, but we have staff working in shifts 24/7 to manufacture tests and provide support as much as we can.”
According to a video posted on the Cepheid YouTube Channel, a majority of the cartridge is produced at the company’s manufacturing plant in Lodi. The empty cartridges are brought to Sunnyvale, where they are filled with the fluids needed for testing.
“This cartridge takes the swab material…liquid sample and then carries out the extraction of a nucleic acid — viral RNA — purification of that, amplification and detection,” said Cepheid’s Chief Medical and Technology Officer, Dr. David Persing, in the video. “This is carried out pretty quickly. By integrating all the fluidics through a rotary valve inside the cartridge. Moving things from chamber to chamber. We’re able to get the reaction fully integrated from extraction to detection.”
Cepheid’s rapid COVID-19 test has the ability to detect SARS-CoV-2 within 45 minutes of taking the test. The test itself uses lab testing equipment that many hospitals across the United States already have in place.
Cepheid created the SARS-CoV-2 test by working 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 and its headquarters is in Sunnyvale.