The U.S. FDA has granted an emergency use authorization (EUA) to Cepheid Inc., of Sunnyvale, Calif., for a rapid molecular diagnostic to detect SARS-CoV-2, the virus that causes COVID-19. The Xpert Xpress SARS-CoV-2 test is designed for the qualitative detection of the novel coronavirus and runs on the company’s automated Genexpert systems, with a turnaround time of about 45 minutes.

“By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly,” said David Persing, Cepheid’s chief medical and technology officer.

Large installed base

Nearly 5,000 Genexpert systems are currently in place across the U.S., capable of point-of-care testing and for use in hospitals. The automated systems can perform testing around the clock and do not require users to have specialized training.

FDA Commissioner Stephen Hahn called the new EUA “an important step in expanding the availability of testing and, importantly, rapid results.”

Cepheid will begin shipping the tests this week, prioritizing regions with the greatest need, and anticipates delivering millions over the coming months, Persing told BioWorld. He said the company is evaluating ways to maximize its production capacity.

“There is more demand than all test makers can currently fulfill, and we’ll see various tests used differently depending on need,” Persing said. “While our test can be used for screening in point of care, we expect the initial use will be for patients and health care workers that currently have the Genexpert system. This will help to rapidly identify carriers and move them quickly to isolation.”

With its 45-minute processing time, Cepheid’s test has an advantage over other coronavirus tests, many of which take days to provide results. During that time, infected patients can pass the virus to others, including health care workers.

“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,” Persing said.

Hospitals are first priority

“The first priority is to supply hospitals with the ability to quickly assign the appropriate infection control and hospital isolation resources to COVID patients and to avoid spending these critical resources on non-COVID patients,” he added. “Right now, negative and positive patients, asymptomatic or not, may unfortunately occupy the same hospital room while waiting for results 24-48 hours later.”

To perform the test, doctors can collect a sample from either a nasal swab or nasal saline wash. One advantage of the wash is that it doesn’t require swabs, which are in high demand and short supply. The test performs real-time PCR to extract RNA from the sample and detect SARS-CoV-2, with “very high sensitivity,” Persing said.

Acquired by Danaher Corp. for $4 billion in 2016, Cepheid has seen greater than 20% growth over the past three years, topping $1 billion in revenue in 2019. On a January earnings call, Danaher CEO Thomas Joyce noted that Cepheid, as well as Integrated DNA Technologies (IDT), were already “taking on this challenge” of the novel coronavirus that was ravaging China and that the companies were supporting CDC efforts to develop qPCR probes and primers to detect the virus.

Cowen analyst Dough Schenkel said the test’s clearance “significantly expands testing capacity given Cepheid’s large installed base (>23K globally; ~5K U.S.). We expect very strong demand for this assay due to its accuracy, speed, and workflow.”

As for scaling to need, he noted that Cepheid’s production capabilities “have significantly improved under Danaher’s ownership, and we believe that Danaher’s ownership of IDT could also reduce the supply chain risk (IDT’s product portfolio includes PCR primer/probes).

Testing capacity growing

The FDA has been churning out EUAs for SARS-CoV-2 tests at a rate of one to two per day over the past week and a half, as hospitals and public health authorities face increasing demand for coronavirus testing. According to Johns Hopkins University, the number of confirmed cases of COVID-19 cases in the U.S. now exceeds 41,500, with more than 475 deaths.

Other companies that have received EUA for SARS-CoV-2 tests include Roche Holdings AG, Abbott Laboratories, Thermo Fisher Scientific Inc. and Novacyt Group. Abbott, which won an EUA for its Realtime SARS-CoV-2 molecular test last week, said it aimed to produce 1 million tests a week by the end of the month.

Meanwhile, Los Angeles-based Scanwell Health announced Friday that it has licensed a rapid serology test from Chinese manufacturer Innovita Biological Technology Co. Ltd. for at-home testing of SARS-CoV-2. The company said the test could be available to Americans within six to eight weeks of attaining EUA from the FDA.