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Cepheid Receives CE Approval for New STD Assays on Their GeneXpert System

Cepheid, Sunnyvale, CA, received CE approval for a new infectious diseases assay on their GeneXpert system. The new assay enables rapid detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). The GeneXpert works with disposable, single-use cartridges that hold the sample and reagent in a small processing chamber. Many assays are already available like the MRSA, enteroviruses and Group B Streptococcus cartridges.

The GeneXpert itself is a closed, self-contained and automated platform. It combines on-board sample preparation with real-time PCR amplification and detection functions for nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences and comes in a one, two, four, or 16-module configuration.

John Bishop, Cepheid’s Chief Executive Officer is cited in the press release:

“We are bringing to market a true next-generation molecular diagnostic product for detection of CT/NG a test designed from the ground up to provide unprecedented accuracy, ease of use, and results availability. We expect these innovative products to deliver new levels of confidence to clinicians making same-day decisions in consulting with, and treating, their patients the critical first step in effectively managing these diseases.”

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