The Biomedical Advanced Research and Development Authority (BARDA) and Cepheid, Inc., are collaborating on development of two COVID-19 diagnostics, the Xpert Pan-Coronavirus test and the Xpert Xpress SARS-CoV-2/Flu/RSV test.
The Xpert Pan-Coronavirus test is designed to detect and differentiate the seven known coronaviruses that infect humans, as well as novel and emerging coronaviruses. In addition to development, Cepheid will perform studies to achieve 510(k) clearance by the U.S. Food and Drug Administration (FDA).
The second project supports achieving expanded claims for the Emergency Use Authorization (EUA) for Cepheid’s Xpert Xpress SARS-CoV-2/Flu/RSV test to allow testing of pooled samples representing multiple individuals from a population. The additional use would allow more rapid testing of multiple people while conserving critical resources. BARDA supported development of this test under an Other Transaction agreement awarded on September 23, 2020.
In addition to addressing SARS-CoV-2 and future emerging coronaviruses, the agreement between Cepheid and BARDA includes options to address pandemic preparedness through development of other diagnostic capabilities. To support this work, BARDA will provide Cepheid with technical expertise and an initial $27 million over the next four years for development of COVID-19 diagnostics.
In the last 20 years, three of the seven coronavirus known to infect humans have caused outbreaks of severe disease – SARS-CoV-1, MERS, and now SARS-CoV-2. The emergence of a future coronavirus is highly likely, and the public health and response community will need comprehensive diagnostic tests such as the Xpert Pan-Coronavirus test to quickly detect the next novel coronavirus.
The Cepheid Xpert Pan-Coronavirus test can rapidly detect the genetic material of novel and/or emerging coronaviruses from individuals with an unidentified respiratory infection. Rapid detection and identification of a novel coronavirus will enable a more rapid response to contain a potential outbreak. The test will operate on Cepheid’s GeneXpert System and Infinity systems in laboratory settings and on the Xpress and Omni systems at the point-of-care. Cepheid currently has more than 5,000 platforms in U.S. laboratories and healthcare facilities and more than 26,000 systems worldwide.
Extension of EUA claims on Cepheid’s Xpert Xpress SARS-CoV-2/Flu/RSV test will allow screening of five to eight people with one test. Each individual sample is pooled into one and tested as a mixed sample. This approach enables screening of multiple people using one sample in less than 30 minutes while saving critical resources. The test currently runs on Cepheid’s GeneXpert System and Infinity systems in laboratory settings and on their Xpress platform at the point-of-care.