California-based Cepheid has developed the United States' first rapid diagnostic test for SARS-CoV-2, the virus that causes COVID-19. The U.S. was lagging behind other countries with regard to the availability of testing in general.
On March 21st, the FDA granted Emergency Use Authorization (EUA) for Cepheid’s, Xpert Xpress SARS-CoV-2 test. This is the first coronavirus test that can be conducted with minimal patient contact and the results delivered within 45 minutes. “This test 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”, said Health and Human Services Secretary, Alex Azar.
The Xpert Xpress SARS-CoV-2 test requires less than a minute of hands-on time to prepare the sample and is designed for use on Cepheid’s GeneXpert® Systems, which have a worldwide footprint of more than 23,000 placements. These systems do not require users to have specialty training to perform the tests.
“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,” he added.
The test looks for the presence of nucleic acid from the SARS-CoV-2 in either a nasopharyngeal swab, nasal wash, or nasal aspirate taken from individuals suspected of COVID-19 by their healthcare provider.
Point-of-care testing means that hospitals, urgent care centers, and emergency rooms, can obtain the results of the tests quickly, instead of waiting for samples to be sent and analyzed by a laboratory. “This marks an important step in expanding the availability of testing and, importantly, rapid results,” said FDA Commissioner Stephen Hahn, M.D.
- Xpert® Xpress SARS-CoV-2 has received FDA Emergency Use Authorization. Cepheid. https://www.cepheid.com/coronavirus
- Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic U.S. Food and Drug Administration March 21, 2020, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-emergency-use-authorization-point-care-diagnostic
- Xpert® Xpress SARS-CoV-2 GeneXpert. Cepheid. https://www.cepheid.com/en_US/package-inserts/1615