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Cepheid Gets OK to Market Molecular Dx Tests in Canada, Mexico

NEW YORK (GenomeWeb News) – Cepheid said today that regulatory authorities in Canada and Mexico have cleared for marketing certain of the firm’s molecular diagnostic tests for hospital-acquired infections.
 
The Sunnyvale, Calif.-based firm said that Health Canada had issued a medical device license for its Xpert GBS, which detects Group B Streptococcus, and Xpert EV for detection of enterovirus-associated meningitis. It said that Fisher Scientific, a division of Thermo Fisher Scientific, will exclusively distribute the tests in Canada.
 
Cepheid received marketing clearance earlier this year from Health Canada for its Xpert MRSA test for detection of methicillin-resistant Staphylococcus aureus.
 
All of the tests run on the firm’s GeneXpert System, an automated molecular diagnostic instrument system that combines on-board sample preparation with PCR amplification.
 
Cepheid also said that regulatory authorities in Mexico had registered the firm’s GeneXpert System, as well as the MRSA, GBS, and EV tests. Those products will be exclusively distributed in Mexico by IL Diagnostics.

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