MRSA, GBS and EV Expand GeneXpert(R) Test Menu in Canada and Mexico
SUNNYVALE, Calif., June 3 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced that Health Canada issued a medical device license for Xpert(TM) GBS, for the rapid detection of Group B Streptococcus (GBS), and Xpert(TM) EV (enterovirus), for the rapid detection of EV-associated meningitis. These tests join Xpert MRSA, which received Health Canada license in January of this year. In Mexico, Cepheid has received registration from the Secretary of Health for its GeneXpert System and Xpert(TM) MRSA, Xpert GBS and Xpert EV tests. The products will be distributed exclusively through I.L. Diagnostics S.A. in Mexico and Fisher Scientific in Canada.
"Regulatory licenses and registrations are critical in our efforts to effectively penetrate these new markets," said Rob Koska, Cepheid's Senior Vice President, Worldwide Commercial Operations. "Both Canada and Mexico will now have access to all of these high medical value-added diagnostic products that are improving patient care throughout the world."
As is the situation in the United States, MRSA is a growing public health concern in Mexico. According to a study published in the Journal of Clinical Microbiology, "The prevalence of resistant bacteria has been increasing rapidly in Mexican hospitals during the last few years. According to different studies performed in the 1980s, 1990s, and 2000, the prevalence of MRSA in Mexican hospitals was estimated to vary from 7 to 30%." Rapid MRSA test results continue to be the cornerstone of the world's most effective surveillance programs.
GBS is a common cause of life-threatening infection in newborns
worldwide. According to the Centers for Disease Control (CDC), there are
still over 1500 annual cases of early onset GBS in the U.S. -- despite
current testing guidelines which recommend screening between 35 and 37
weeks of gestation. However, this does not protect against the
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