NEW YORK (GenomeWeb News) – Cepheid today said that Canadian regulatory authorities have cleared for marketing the firm’s molecular diagnostic assay for methicillin-resistant Staphylococcus aureus and Staphylococcus aureus in skin and soft tissue infections.
The Xpert MRSA/SA SSTI test runs on Cepheid’s GeneXpert System and can provide test results in less than an hour. The firm noted that its test is the first molecular SSTI diagnostic for MRSA and SA to be cleared in Canada.
Cepheid received US Food and Drug Administration clearance for the test in September.
This is the fifth of Cepheid’s tests to gain Canadian clearance. It also has a MRSA/SA Blood Culture test and Xpert HemosIL test under regulatory review in Canada.