The firm expects to receive an Emergency Use Authorization soon from FDA, followed by a filing for full FDA clearance. A company official also updated investors on Cepheid's pipeline of tests.
Prodesse will market the SmartCycler along with its PCR tests in the US.
While its total revenues were down 3 percent, the firm's clinical reagents sales grew 54 percent.
The FDA cleared Cepheid's C. difficile test to run on its GeneXpert System. The firm expects to begin shipments next week.
In Brief This Week is a Friday column containing news items that our readers may have missed during the week.
Cepheid and the University of Medicine and Dentistry of New Jersey will work on developing a 10-color detection technology for the firm's GeneXpert System.
The GWDN Index of 36 molecular biology tools and molecular diagnostics makers gained ground for the second month in a row, with Affymetrix rising significantly during that time period. Sequenom's tumble occurred on the final day of the month.
The test simultaneously identifies Mycobacterium tuberculosis and resistance to first-line drug therapy rifampicin.
Cepheid's new assay is the 10th Xpert molecular test to receive the CE-IVD Mark.
Mari Baker is leaving Navigenics, Andrew von Eschenbach has joined a consulting firm, Jay Flatley takes a seat on Helixis' board, and more.
Bloomberg reports that the DNA-for-cash deal reported in Kentucky might be a more widespread scam.
St. Jude Children's Research Hospital scientists have treated infants with X-linked severe combined immunodeficiency using gene therapy in an early phase study.
St. Louis Public Radio reports that some African Americans are turning to DNA ancestry testing to help guide genealogical searches.
In Nature this week: a genomic analysis of the snailfish Pseudoliparis swirei, ancient DNA analysis gives insight into the introduction of farming to England, and more.