FDA Authorizes Rapid Point-of-Care SARS-CoV-2 Diagnostic

The US Food and Drug Administration (FDA) has issued an emergency use authorization for Cepheid's point-of-care COVID-19 diagnostic, Xpert Xpress SARS-CoV-2, according to a statement from the agency.

The test was designed to provide detection of SARS-CoV-2 in approximately 45 minutes, following specimen collection from a nasopharyngeal swab and nasal wash or aspirate. Cepheid plans to begin shipping the test by March 30.

“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” Stephen Hahn, MD, FDA Commissioner, said in a statement. “Today marks an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

The Xpert Xpress SARS-CoV-2 test cartridge is designed to detect nucleic acid from SARS-CoV-2 via real-time polymerase chain reaction. The cartridge contains a complete solution and does not require the use of reagents, according to information available from the company. The GeneXpert System is required to run the test in a CLIA-approved laboratory or select patient care settings.

"Cepheid currently has nearly 5000 GeneXpert Systems in the US capable of point-of-care testing and for use in hospitals," Warren Kocmond, president of Cepheid, said in a statement. "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."

The FDA's emergency use authorization program allows unapproved products to be used in the context of a public health crisis, such as the SARS-CoV-2 pandemic. A number of other diagnostics have already gained emergency use authorization; however, the Xpert Xpress SARS-CoV-2 test is the first point-of-care option.

“With the development of point of care diagnostics, Americans who need tests will be able to get results faster than ever before. More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace, thanks to the hard work of our FDA team and the ingenuity of American industry," said Alex Azar, HHS Secretary. "With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them.”

At the time of the FDA's authorization, there were over 300,000 globally reported confirmed cases of COVID-19, with the number rapidly growing in the United States to beyond 24,000. Diagnostics, as well as personal protective equipment, remain an ongoing challenge in the fight against the coronavirus.

"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, MD, PhD, chief medical and technology officer at Cepheid, said in a statement. "An accurate test delivered close to the patient can be transformative and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources."

For the most recent case counts in the COVID-19 outbreak, check out the Contagion® Outbreak Monitor