CPHD Cepheid Initiates CE IVD Products in Europe With Launch of GeneXpert(R) System and Xpert BCR-ABL Monitor(TM) Assay
PR Newswire - February 23, 2006 7:01 AM (EDT)
SUNNYVALE, Calif., Feb 23, 2006 /PRNewswire-FirstCall via COMTEX/ -- Cepheid (Nasdaq: CPHD), a broad-based molecular diagnostics company, today announced the European launch of the GeneXpert(R) System for in vitro diagnostic use (IVD) along with the Xpert BCR-ABL Monitor(TM) assay, the initial clinical diagnostic test for use on the GeneXpert(R) System. Both the GeneXpert System and the Xpert BCR-ABL Monitor assay were released as "Conformite Europeene" or "European Conformity" CE IVD Mark products under the European Directive on In Vitro Diagnostic Medical Devices. The Xpert BCR-ABL Monitor can be used by hematologist-oncologists and labortorians as an aid in the monitoring of BCR-ABL, an abnormal genetic marker found in patients with Chronic Myelogenous Leukemia (CML).
"The GeneXpert(R) System has been demonstrated to be robust, easy to use and capable of delivering sensitivity and specificity not previously seen in molecular testing," said John Bishop, Cepheid CEO. "In the European clinical molecular diagnostics market the ability of the clinician to obtain immediately actionable intelligence is critical to patient management. We believe the GeneXpert(R) System is in a unique position to deliver on this clinical need."
The GeneXpert System and the Xpert BCR-ABL Monitor assay is the world's first closed system, quantitative, nested real-time PCR (polymerase chain reaction) assay. This assay allows healthcare providers in Europe to obtain timely, near-patient, highly sensitive and accurate results from a blood sample, with minimal potential for RNA loss or sample contamination. The GeneXpert System combines sample preparation with real time nested PCR amplification and detection for fully-automated DNA and RNA analysis. The system purifies, concentrates, detects and identifies targeted nucleic acid sequences. The BCR-ABL assay provides in approximately 2 hours. Current techniques for performing the same complex sample prep, reverse transcription, and PCR procedures involve skilled technicians in centralized molecular labs performing batched manual tasks that can take two to three days to complete.
Chronic myelogenous leukemia (CML) is part of a group of diseases called myeloproliferative disorders. There are approximately 20,000 CML patients living in remission in Europe today. Current Europe Against Cancer Program practice guidelines for management of patients with CML call for use of quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) assays during the initial workup of patients with chronic phase CML and in monitoring for minimal residual disease, and in identifying patients who may be at a high risk for relapse. Patients may have their blood tested as many as four times a year.
The GeneXpert(R) System is currently the only real-time PCR platform that integrates microfluidic sample preparation with the sensitivity of real-time polymerase chain reaction (PCR) based molecular detection resulting in the first easy-to-use system in this field. The GeneXpert(R) System was released in the Biothreat surveillance market in 2004 and has subsequently been proven to be an extremely robust and accurate platform technology with over 1,100 modules and systems in the market generating over 2.1 million anthrax test results.
