Amid a global COVID-19 pandemic, one of the most critical areas is being able to test people showing symptoms to prevent further spread of the disease. Until earlier this week, the testing process could take up to a week, but thanks to a new test developed by Cepheid, that time could be cut to as short as 45 minutes.
Right now, hospitals, drive-thru testing sites and other test locations can’t process the tests on-site, said Dr. David Persing, Cepheid’s chief medical and technology officer, in a video announcing the new test. Instead, batches of tests are sent to a central lab, and that can add days of turnaround time.
“And for real-time patient management decisions to be made in hospitals, what’s really needed is a test that can rapidly determine status of infection on-site when patients are being seen, being admitted,” he said.
Cepheid thought they could do better.
The company, which is based in Sunnyvale and has a production plant in Lodi, has developed a test for SARS-CoV-2 — the novel coronavirus that causes COVID-19 — that takes about 45 minutes to complete.
The test relies on Cepheid’s existing GeneXpert system, a medical testing system that has been available for more than a decade.
“One of the major advantages that we have is that our systems are already in many if not most hospitals in the U.S. They’re already there, ready to be used for this test,” Persing said.
More than 23,000 of the systems, which can test from two to 80 samples at a time, have been implemented around the world. The Cepheid tool already tests for infections like the flu, tuberculosis, strep and HIV; now, it can be used for COVID-19 as well.
“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,” Cepheid President Warren Kocmond said in a March 21 press release.
Using the GeneXpert system, a health care provider could take a sample such as a nose or throat swab, a Cepheid spokesperson said. At that point, the sample is used to prepare a specialized cartridge, many of which are made at the Lodi plant.
Each cartridge can be prepared in under a minute, and then it is loaded into the GeneXpert system. In approximately 45 minutes, the system returns results.
“We think this will be a very important tool in being able to get rapid, actionable results, to let patients know if they’re carriers, even if they’re asymptomatic, to quarantine, and to know that they’re being quarantined for a reason — not because they may have hay fever or some other cause, but to really give them a reason for quarantine,” Persing said.
Cepheid’s researchers leveraged the work they did in creating tests for the flu and respiratory syncytial virus, which use those viruses’ genomes for quick detection, a Cepheid spokesperson said. The test uses viral RNA, amplifying genetic data removed from each sample and analyzing it.
Cepheid worked with the U.S. Food and Drug Administration to get quick approval, via their Emergency Use Authorization, and began developing their test in January. The company also worked with the U.S. Department of Health and Human Services and the U.S. Department of Defense in developing their test.
The test was approved by the FDA on March 21. Cepheid is now working with other countries around the world to get their testing process approved in other COVID-19 hot spots.
The company has ramped up production of the tests and cartridges to meet the rapidly growing demand, according to a spokesperson. Cepheid plans to produce millions of tests in the coming months, and the first tests are scheduled to ship out next week.
“Knowing someone’s status — infection status — coming in allows us to be a lot more vigilant about hospital exposure,” Persing said.
For example, it would keep patients with coronavirus-like symptoms from being kept with COVID-19 patients if what they actually have is the flu or other respiratory infection. It would also prevent patients with mild symptoms from spreading COVID-19 accidentally.
“If we can flatten the curve, we can minimize the overall effects of this on our hospitals especially ... and also give us a chance for some of the new therapies to come into play that are in development — rapid development — right now,” Persing said.
To see a video of how the GeneXpert and Xpert Xpress SARS-CoV-2 work, visit youtu.be/2s4KxC4M8Gw. To watch Persing’s full statement or find more information about Cepheid’s new test, visit www. cepheid.com/coronavirus.