Cepheid 2013 sales of CT/NG estimated $15M-$20M at William Blair William Blair expects solid initial demand for Cepheid's just approved Xpert CT/NG from existing Xpert customers and projects 2013 sales between $15M-$20M on a worldwide basis. However, William Blair says it is not sure if Cepheid will be able to ship enough product to meet initial demand as it provided no update on the recent manufacturing issues. The firm keeps an Outperform rating on the stock.
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.