SUNNYVALE, Calif. — 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. A unique molecular diagnostic platform, the system has a menu of current and expected tests that span the Healthcare Associated Infection, Oncology, Women’s Health, Critical Infectious Disease, Immuno-Compromised, and Genetics markets. With an installed clinical base of over 1,000 GeneXpert Systems worldwide, the platform offers the potential to standardize molecular-based testing in laboratories and healthcare institutions.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial and biothreat markets. The company’s systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company’s easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See http://www.cepheid.com for more information.
1. Central European Leukemia Study Group 2007. About CML; http://www.cml-info.com/de/healthcare-professionals/about-cml.html
This press release contains forward-looking statements that are not purely historical regarding Cepheid’s or its management’s intentions, beliefs, expectations and strategies for the future, including those relating to product performance, future products and future market opportunities. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the company’s current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: unforeseen manufacturing problems; unexpected delays in the development process; uncertainties related to regulatory approval of new products; unexpected issues arising from clinical trials of proposed products; regulatory developments and changing practices regarding testing; customer and market acceptance of products; pricing of new products; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for products; the potential need to acquire or license intellectual property for new products; and the uncertain impact of the global economic downturn. Readers should also refer to the section entitled “Risk Factors” in Cepheid’s Annual Report on Form 10-K for 2008, filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.
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