Cepheid Announces International Commercial Availability Of Next Generation BCR-ABL Test

Xpert BCR-ABL Ultra Assesses Deep Molecular Response in Chronic Myeloid Leukemia Patients on Treatment with Tyrosine Kinase Inhibitors

Dec 08, 2015, 08:00 ET from Cepheid

SUNNYVALE, Calif., Dec. 8, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced the commercial availability outside the United States of Xpert® BCR-ABL Ultra, a quantitative measure of BCR-ABL1 mRNA transcripts (types e13a2/b2a2 or e14a2/b3a2) that allows physicians to monitor the effectiveness of therapy in their patients with Chronic Myelogenous Leukemia (CML) with enhanced sensitivity. 

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 development of Tyrosine Kinase Inhibitors (TKIs) that target BCR-ABL has transformed CML from a uniformly fatal illness into a manageable chronic disease for many patients, and new data now suggest that for a subset of patients with consistently deep molecular response (at least a 4.5 log reduction from baseline levels of BCR-ABL1 transcript), TKI therapy might be discontinued altogether without further recurrence of the disease. 

"Until now, tests for BCR-ABL were not standardized, and could not be reliably compared in one lab and certainly not across borders, making patient management quite challenging," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.  "Because Xpert BCR-ABL Ultra is aligned to the International Scale on a lot-to-lot basis, accuracy and comparability of results is assured no matter where in the world the test is performed.  In addition, the added sensitivity provides physicians with the information they need to confidently optimize individual treatment strategies for their patients with CML, including identifying patients who might be considered for a trial of therapy discontinuation."

"The launch of Xpert BCR-ABL Ultra will further support the mission of The Max Foundation, enabling hematologists to optimize clinical outcomes, and patients to maximize their potential," added Pat Garcia-Gonzalez, MS, Chief Executive Officer of The Max Foundation.  "The sensitivity, reliability, and benefits of a point of care molecular diagnostic instrument such as the GeneXpert System cannot be overstated.  It has already allowed us to bring molecular diagnostics to regions of the world where none existed before, giving patients a chance of a future for the first time."

"The Xpert BCR-ABL Ultra assay solves many of the existing challenges in monitoring molecular response in patients with Chronic Myeloid Leukemia with accuracy, precise international standard calibration, and speed," added Michael J. Mauro, M.D. head of the Myeloproliferative Neoplasms Program at Memorial Sloan Kettering Cancer Center1. "By aligning to the International Scale on a lot-to-lot basis, Xpert BCR-ABL Ultra addresses ongoing concerns about the effect of variability in testing methodologies on the accurate assessment of treatment responses."

Xpert BCR-ABL Ultra runs on the Cepheid GeneXpert® System, the world's leading molecular diagnostic platform with over 9,200 systems deployed globally in both developed and emerging market countries. Xpert BCR-ABL Ultra delivers results in less than two and a half hours, with minimal hands-on time, and with the ease-of-use for which the GeneXpert System is well known. 

Xpert BCR-ABL Ultra begins shipping this week as a CE-IVD Mark product. For more information on Cepheid's GeneXpert Systems or the complete menu of CE-IVD Xpert tests, visit www.cepheidinternational.com.

About Cepheid

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 www.cepheid.com.

About GeneXpert Systems and Xpert Tests

With more than 9,200 systems in 182 countries, the GeneXpert System is the world's most popular molecular diagnostics' instrument.  The GeneXpert System's modular configuration means that the system is the most scalable available, offering the ability to perform from one to eighty Xpert tests at the same time.  As a result, the GeneXpert System meets the throughput requirements of customers of all sizes - from lower volume point-of-care settings to higher volume reference laboratories – enabling accurate, fast and cost effective test results.

GeneXpert Systems run proprietary Xpert test cartridges.  The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious disease, and oncology, and today offers 24 tests outside the US, and 18 tests in the US.  More information on the GeneXpert System and the Xpert tests is available on our website at www.cepheid.com

Forward Looking Statements

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 the future availability, performance, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of the GeneXpert System and Xpert tests, including relative to competing products and technologies.  Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from Cepheid's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: test performance in the field; utilization of our tests by clinicians and future changes in medical practice and protocols; our ability to successfully and timely develop new products; the completion of clinical trials for new products successfully and in a timely manner; uncertainties related to the United States FDA, European and other regulatory processes; the Company's ability to successfully introduce and sell products in global markets; the Company's research and development budget; unforeseen supply, development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; the impact of competitive products and pricing; the costs of product components and other factors affecting product pricing; the Company's ability to manage geographically-dispersed operations; and underlying regulatory, political and market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports 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.

1Dr. Mauro was part of a multicenter, prospective evaluation of the Xpert BCR-ABL Ultra Assay.  Data from this evaluation is included in the clinical data supporting the release of the test outside the US and was recently presented at the 17th Annual John Goldman Conference on Chronic Myeloid Leukemia: Biology and Therapy 2015 (Estoril, Portugal), "Clinical Evaluation of Xpert® BCR-ABL Ultra, an Automated and Standardized Cartridge-Based Assay for the Quantification of BCR-ABL1 (Abstract #4221).

For Cepheid Media & Investor Inquiries: Jacquie Ross, CFA +1 408-400-8329 corporate.communications@cepheid.com

SOURCE Cepheid



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