Emergency Use Authorization (EUA) has been granted by the Food and Drug Administration (FDA) for California-based Cepheid’s Xpert Xpress SARS-CoV-2 test.
This is the first coronavirus test that can be conducted with minimal patient contact and results delivered within 45 minutes. “The 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.
“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 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.
The test looks for the presence of nucleic acid from SARS-CoV-2 in either a nasopharyngeal swab, nasal wash, or nasal aspirate taken from individuals suspected of having COVID-19 by their healthcare provider.
“This marks an important step in expanding the availability of testing and, importantly, rapid results,” said FDA Commissioner Stephen Hahn, M.D. The U.S. was lagging behind other countries with regard to the availability of testing in general.
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.
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/Package%20Insert%20Files/Xpress-SARS-CoV-2-PI/302-3562-rev%20A-PACKAGE-INSERT-EUA-GX-SARS-COV2.pdf
Posted: March 2020