An innovative Covid-19 testing system born out of Silicon Valley that can reduce result delivery time from days to just 45 minutes has received emergency approval from the Food and Drug Administration and is ready to be rolled out nationwide to help ease America’s dire coronavirus situation.
Announcing the regulatory clearance on Saturday, Cepheid, the Sunnyvale, Calif.-based company behind the approved technology, GeneXpert Systems, said test kits will begin shipping next week and be available by the end of March.
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Cepheid’s testing system is the first point-of-care Covid-19 device approved by the FDA, meaning that tests can be performed by a patient’s bedside or at a doctor’s office, rather than a special lab. Until now, testing the coronavirus requires a nurse to take a swab from the back of a patient’s nose and then send the sample to one of the 91 CDC-authorized labs in the country. The whole process often takes days to return results.
“During this time of increased demand for hospital services, clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health care facilities,” David Persing, Cepheid’s chief medical and technology officer, said in a statement over the weekend.
Large-scale adoption of Cepheid’s fast testing technology—and possibly other point-of-care test systems—means that the U.S. could see a surge of reported Covid-19 cases in the coming days. But the upshot is that health care authorities will have a clearer understanding of the true degree of the pandemic and therefore implement more effective containment measures. Expansive tests have proven to be the single most important element in successfully slowing down Covid-19’s spread in other hard-hit countries, including China, Korea and Japan.
“An accurate test delivered close to the patient can be transformative,” Persing added, “and help alleviate the pressure that the emergence of the [Covid-19] outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.”
Cepheid currently has about 5,000 GeneXpert Systems in the U.S. capable of point-of-care testing and for use in hospitals, said Cepheid President Warren Kocmond. “Our automated systems do not require users to have specialty training to perform testing—they are capable of running 24/7, with many systems already doing so today.”
On Sunday, Vice President Mike Pence, head of President Donald Trump’s coronavirus task force, said during a press briefing that 254,000 U.S. citizens have been tested for the coronavirus at public health labs. About 30,000 of them were tested positive.
“There’s a bit of an encouraging word in that,” Pence said. “It’s working out to be that one in 10 Americans who have been tested and thought they had coronavirus actually had it. Nine out of 10 did not.”
At press time, 33,404 people in the U.S. have been diagnosed with Covid-19, according to CDC’s latest count.
