Enterovirus Assay Submitted for FDA Clearance

Cepheid has submitted its Enterovirus (EV) assay Xpert EV™ for use on the GeneXpert System to the U.S. Food & Drug Administration for regulatory clearance. Cepheid is seeking clearance of this assay as a laboratory test to aid in the detection of EV-associated meningitis.

The GeneXpert System, a closed, self-contained, fully-integrated and automated system, produces accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real time PCR amplification and detection functions for fully integrated and automated nucleic acid analysis.

The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences and deliver answers from unprocessed samples for EV in less than 3 hours, where other testing methods may take upward of three days.