The GeneXpert® System(a closed, self-contained, fully-integrated and automated system) is the only system to combine on-board sample preparation with real time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. This system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences and deliver answers from unprocessed samples for Enterovirus(EV) in less than 3 hours, where other testing methods may take three days or more.
The GeneXpert® System is developed by Cepheid, a molecular diagnostics company based in Sunnyvale, California, that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial and biothreat markets.
Today, 17th April Cepheid submitted its Xpert EV™ (Enterovirus) Assay for use on the GeneXpert® System to the USFDA for regulatory clearance. The company is seeking clearance of this assay as a laboratory test to aid in the detection of EV-associated meningitis.
“The diagnosis of enteroviral infection by RT-PCR testing is a critical component of the management of patients with suspected meningitis, but the test is not widely available outside of medical centers that have sophisticated molecular diagnostics laboratories. Even in medical centers with existing laboratory capacity, the test is not usually available around the clock even though there is significant value in a rapid result,” said Cepheid Executive Vice President, Chief Medical and Technology Officer, David H. Persing, M.D., Ph.D.