USFDA Approves Cepheid’s Rapid, Point-of-Care COVID-19 Test

By Rajaneesh K. Gopinath, Ph.D.

This morning, California-based Cepheid announced the USFDA’s Emergency Use Authorization (EUA) for its rapid, SARS-CoV-2 detecting, real-time RT-PCR test. Named Xpert® Xpress, this molecular diagnostic test can give results within 45 minutes, which is faster than any other tests currently available. With the pandemic spreading fast in the country, the Trump administration was originally criticized for its lapse in preventive actions and the shortage of diagnostic tests. However, in the past couple of weeks, several measures including emergency FDA approval of coronavirus tests have been taken by authorities. Cepheid’s test has now become the eleventh since March 12th and thirteenth overall to bag emergency approval after big players like Roche and Thermo Fisher.

However, it is the first point-of-care coronavirus test to be approved and is designed to operate on any of Cepheid’s preinstalled automated instruments by users without any specialty training. The company says, at present, there are 23,000 GeneXpert® systems around the world with 5,000 of them in the US alone. The point-of-care nature and rapid delivery of results give Cepheid’s test the edge over others. “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” said FDA Commissioner Stephen Hahn.

GeneXpert® Systems (Image Courtesy: Cepheid)

“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. 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,” said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid in a statement.

“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” he added.

Related Article: Abbott’s Homemade Coronavirus Test bags FDA’s Emergency Authorization

References

1. http://cepheid.mediaroom.com/2020-03-21-Cepheid-Receives-Emergency-Use-Authorization-from-FDA-for-Rapid-SARS-CoV-2-Test
2. https://www.fda.gov/media/136316/download

Author

Rajaneesh K. Gopinath