FDA Authorizes New COVID-19 Diagnostic Test with Rapid Detection

Officials with the FDA today issued emergency use authorization of a rapid, point-of-care COVID-19 diagnostic test, developed by Cepheid, that has a detection time of approximately 45 minutes, according to a press release.^1,2

The Xpert Xpress SARS-CoV-2 is a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19, according to Cepheid.²

The agency issued an emergency use authorization to Cepheid for the test’s use in high- and moderate-complexity CLIA-certified laboratories, as well as in certain patient care settings.¹

Cepheid will begin shipping the product next week, according to the company.²

“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.² “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 health care facilities that need to properly allocate their respiratory isolation resources.”

According to Warren Kocmond, president of Cepheid, their automated systems do not require users to have specialty training to perform testing and are capable of running 24/7.²

“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort,” HHS Secretary Alex Azar said in a statement.¹ “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.”

References:

1. Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic [news release]. FDA’s website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-emergency-use-authorization-point-care-diagnostic. Accessed March 21, 2020.

2. Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test [news release]. Cepheid’s website. http://cepheid.mediaroom.com/2020-03-21-Cepheid-Receives-Emergency-Use-Authorization-from-FDA-for-Rapid-SARS-CoV-2-Test. Accessed March 21, 2020.