NEW YORK – The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority, or BARDA, announced recently that it has awarded Cepheid $28 million in total for product development related to its SARS-CoV-2 tests.
According to BARDA, the award is for the firm's Xpert Xpress SARS-CoV-2 test, which detects viral nucleic acid in upper respiratory samples and was developed in partnership with BARDA and the US Department of Defense; its Xpert Pan-Coronavirus test that will detect and differentiate between seven known coronaviruses that infect humans, including SARS-CoV-2; and its Xpert Xpress SARS-CoV-2/Flu/RSV test that differentiates COVID-19, influenza A/B, and respiratory syncytial virus.
A spokesperson for Cepheid, which is part of Danaher, however, said that the $28 million is only for work on the Xpert Pan-Coronavirus and the Xpert Xpress SARS-CoV-2/Flu/RSV tests.
The SARS-CoV-2-only test received Emergency Use Authorization from the US Food and Drug Administration in December for specimens collected by healthcare providers. It has been validated for use with pooled samples containing up to eight specimens and runs on the firm's GeneXpert Dx, GeneXpert Infinity, and GeneXpert Xpress systems.
Its multiplex RT-PCR test received EUA in September for use in high and moderate complexity laboratories and at the point of care. It runs on the GeneXpert Dx and GeneXpert Infinity instruments.
The pan-coronavirus panel has not yet received EUA and is still in development but will operate in the lab and point-of-care spaces on the GeneXpert system. The test will also enable detection of novel and emerging coronaviruses that spill over into the human population, BARDA said on its website.