Cepheid announces European release of Xpert Norovirus Cepheid announced the release of Xpert Norovirus, a qualitative in vitro diagnostic test for rapid identification and differentiation of Noroviruses genogroup I and genogroup II, to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The test runs on Cepheid's GeneXpert System.
Cepheid receives FDA emergency use authorization for Xpert Ebola diagnostic test Cepheid announced it has received Emergency Use Authorization from the FDA for Xpert Ebola, a molecular diagnostic test for Ebola Zaire Virus that delivers results in less than two hours. The test runs on the Cepheid GeneXpert Systems. Xpert Ebola has been authorized by FDA under an Emergency Use Authorization for use by CLIA moderate and high complexity laboratories or similarly qualified non-U.S. laboratories. The test will begin shipping in April. Cepheid's Xpert Ebola has not been FDA cleared or approved, but will remain available in the U.S. as an EUA product as long as the declared emergency remains in effect or it ceases to be authorized by FDA.