Oncology Test Further Highlights Broad Market Applicability of GeneXpert System
SUNNYVALE, Calif., June 17 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced the release of its improved Xpert(R) BCR-ABL Monitor test to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. With improved time-to-results, the test now detects the BCR-ABL chromosomal translocation in about 2 hours as compared to 2.5 hours for the original product release. The test is intended to aid European clinicians in the monitoring of patients with Chronic Myelogenous Leukemia (CML). The test runs on Cepheid's GeneXpert(R) System, the world's leading on-demand molecular diagnostic platform.
'The GeneXpert System is capable of producing unheard of sensitivity levels for a molecular system - a potential key benefit in monitoring minimal residual disease,' said John Bishop, Cepheid's Chief Executive Officer. 'Similar to our recently announced test for Mycobacterium tuberculosis, Xpert BCR-ABL Monitor uses nested PCR, a critical amplification process possible only within a fully closed integrated molecular sample prep/test system. We will continue to extend the many unique benefits of the GeneXpert System across multiple markets and testing applications.'
Worldwide, CML affects 1 to 2 people per 100,000 annually.(1) The 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. Patients may have their blood tested as often as four times a year.
'Cepheid's Xpert BCR-ABL Monitor test is a powerful tool for monitoring patients being treated for Chronic Myelogenous Leukemia,' said Dr. Ellie Nacheva, MD PhD FRCPath, Head of Lab - Leukemia Cytogenetics, Royal Free and University College School of Medicine. 'The unsurpassed sensitivity of the GeneXpert System enables clinicians to process molecular tests in their own facilities instead of sending patient samples to a central lab and waiting for results. A patient's local clinician can now monitor minimal disease levels very quickly - the key to appropriately managing patients who may be at risk for relapse.'
The improved Xpert BCR-ABL Monitor test highlights the broad market applicability of Cepheid's GeneXpert System.
