Cepheid MRSA test
This article was originally published in The Gray Sheet
Executive Summary
Firm's Xpert MRSA rapid molecular test for methicillin-resistant staphylococcus aureus - the leading cause of hospital-acquired infections - is designated as "moderate complexity" for use in and outside of hospitals' traditional laboratory setting May 22 under the Clinical Laboratory Improvement Amendments. The test, FDA-cleared in April, is the first molecular MRSA test with this CLIA designation, according to Cepheid. The firm reported sales of $22.1 million in the first quarter, up 15% from the prior-year period. Cepheid expects the U.S. introduction of Xpert MRSA and Xpert EV, a rapid molecular test cleared in March for viral meningitis, to push it to profitability by the end of the year, with 2007 product sales guidance of $100 million-$105 million...