Cepheid Announces Release of Updated Xpert BCR-ABL Monitor Test
CE-IVD Test Now Incorporates Lot-Specific Standardization Using WHO Standards
SUNNYVALE, Calif., July 25, 2012 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced the release of an updated Xpert® BCR-ABL Monitor test, now incorporating lot-specific standardization using the WHO (World Health Organization) BCR-ABL standards. The test is being released as a European CE-IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. The test, which runs on Cepheid's GeneXpert® System, detects the BCR-ABL mRNA transcript in the peripheral blood of patients with Chronic Myelogenous Leukemia (CML) in about two hours.
"Our work in the CML area is the first of several initiatives we are developing as we extend the GeneXpert System test menu into a new line of molecular diagnostic oncology products," said John Bishop, Cepheid's Chief Executive Officer. "The new lot-specific standardization translates to even greater clinical accuracy for physicians as they compare BCR-ABL values over time within the same patient, as well as comparability across geographic locations where testing is being performed."
"We have used and endorsed Xpert BCR-ABL Monitor in our research efforts for several years," commented Dr. Jerald Radich, head of the Molecular Oncology Lab at the Fred Hutchinson Cancer Research Center. "Lot-to-lot standardization to the WHO benchmark improves reliability and comparability between labs. This will facilitate both patient care and clinical research studies which rely on BCR-ABL testing as a benchmark of response."
CML is a cancer of the myeloid lineage of leukocytes (white blood cells) that is characterized by the presence of the "Philadelphia Chromosome," a reciprocal translocation of chromosomes 9 and 22 that results in the generation of the BCR-ABL fusion gene. The BCR-ABL protein functions as a constitutively activated tyrosine kinase that drives the proliferation of immature myeloid cells.
If untreated, CML progresses within several years from a chronic phase to accelerated phase or blast crisis, where survival is often measured in months. The introduction of the targeted Tyrosine Kinase Inhibitors (TKIs) imatinib, dasatanib, and nilotinib has had a profound impact on the survival of patients with CML. Since their introduction, CML has been transformed into a chronic condition with a good long-term prognosis. Monitoring the levels of BCR-ABL mRNA transcript in the blood of CML patients on TKIs using real-time quantitative PCR has become standard of care in the management of CML. The goal of treatment is to reach a major molecular response (MMR), defined as a 3 log reduction (< 0.1%) in BCR-ABL mRNA levels from a standardized baseline as defined by the International Scale1,2. In order to accurately assess treatment response, it is essential that variability in testing methodologies be tightly controlled. This has resulted in substantial efforts to standardize BCR-ABL molecular testing across laboratories by introducing an International Scale3,4.
Cepheid has now enhanced this validation effort by controlling variation between each lot of manufactured product. The updated Xpert BCR-ABL Monitor, with lot-specific standardization, is now available as a CE-IVD Mark product. For more information on Cepheid's GeneXpert Systems or complete menu of CE-IVD Xpert tests, visit www.cepheidinternational.com.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
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 planned new product releases and product performance. 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; uncertainties in the regulatory review process for new products; regulatory developments and practices regarding testing protocols; customer and market acceptance of our products; the failure of products to perform as fast or as accurately 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 the products; and underlying market conditions worldwide, particularly in Europe. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2010 and in its most recent quarterly report on Form 10-Q, each 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.
- NCCN Guidelines™ version 2.2011 Chronic Myelogenous Leukemia
- Baccarani M et.al. Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet. J Clin Oncol. 2009 Dec 10;27(35):6041-51. Epub 2009 Nov
- Cayuela JM., Cartridge-based automated BCR-ABL1 mRNA quantification: solving the issues of standardization, at what cost? Haematologica. 2011 May;96(5):664-71. Epub 2011 Feb 17
- O'Dwyer, M.E. et. al. Analysis of the GeneXpert System on the International Multicentre ICORG 08-02 Phase II Study of Nilotinib300mg BID as Frontline Treatment in Patients with Early Chronic Phase Chronic Myeloid Leukemia (ECPCML) 2011 ASH poster presentation
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