With the COVID-19 pandemic entering a new phase, the Biomedical Advanced Research and Development Authority (BARDA) continues to emphasize testing in addition to the growing number of vaccines, and as such, has entered a new agreement with Cepheid, Inc. to develop two additional diagnostics.
These diagnostics are respectively known as the Xpert Pan-Coronavirus test and the Xpert Xpress SARS-CoV-2/Flu/RSV test. The Xpert Pan test will detect and distinguish between the seven known coronaviruses that infect humans, along with emerging coronaviruses. In the case of Xpert Xpress, the test will allow testing of pooled samples from multiple individuals within a population to provide more rapid testing of multiple people and conserve critical resources.
Under the pair’s arrangement, Cepheid will perform studies to achieve 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Xpert Pan test and move toward gaining Emergency Use Authorization for the Xpert Xpress test. Further, the agreement offers options to develop other diagnostics, and with everything on the table, offers Cepheid $27 million and technical expertise for four years to develop these items. BARDA has already provided support for the Xpert Xpress test as part of an Other Transaction agreement.
The Xpert Pan test will work through Cepheid’s GeneXpert System and Infinity systems in lab settings, as well as on the Xpress and Omni systems at point-of-care facilities. There are currently more than 5,000 of these platforms throughout the United States, and more than 26,000 distributed worldwide.
If approved for use under a new EUA, the Xpert Xpress test would be allowed to screen between five to eight people with each diagnostic. It would do this by pooling samples into a mixed sample to allow screening of multiple individuals at once in under 30 minutes. It can be used in both lab settings — through the GeneXpert or Infinity systems — or at point-of-care with the Xpress platform.