January 2010 Clinical Laboratory News: Industry Profiles

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January 2009: Volume 36, Number 1

bioMérieux, GSK to Develop Test for Breast Cancer

bioMérieux signed an agreement with GlaxoSmithKline (GSK) to develop a test to select appropriate treatments for breast cancer patients. The test, based on emerging biomarkers, will be intended for use in both adjuvant and metastatic breast cancer patients. “This new collaboration is a significant milestone in our ‘theranostics’ strategy,” said Stéphane Bancel, CEO of bioMérieux. “Working with GSK, we hope to achieve an important breakthrough in breast cancer care, helping oncologists to determine the most appropriate treatment as early as possible to give a significant number of breast cancer patients the chance for a better outcome.” The new test will be developed by bioMerieux and its subsidiary, bioTheranostics; GSK will provide expertise in conducting clinical trials and access to samples from other clinical trials.

CVS to Offer PGx Testing with Generation Health

CVS Caremark (CVS), the nation’s largest pharmacy healthcare provider, and Generation Health, Inc., a genetic benefit management company, announced a partnership to offer pharmacogenomic (PGx) clinical and testing services for pharmacy benefit management (PBM) clients who are either non-responsive or have adverse reactions to their medications. The overall goal of the partnership is to improve individual health and reduce medical costs by using genetic testing to manage drug prescriptions. The companies will initially focus on PGx testing programs that predict how patients respond to medications in the areas of oncology, cardiovascular medicine, and HIV treatment.

“Personalized medicine is a fast-growing field, but the process for providing relevant and systematic clinical delivery of service needs to improve and evolve,” said Troyen A. Brennan, MD, executive vice president and chief medical officer of CVS. “We will integrate Generation Health’s unique skills in genomic medicine with the expertise in benefit management of both companies to provide clients with a sophisticated, evidence-based approach.” The PGx services from this partnership are expected to be introduced to CVS PBM clients in the second quarter of 2010. As part of the agreement, CVS will make a minority equity investment in Generation Health and Brennan will join its board of directors. No additional financial terms of the agreement were disclosed.

Abbott, BG Medicine to Collaborate on New Heart Failure Test

Abbott and BG Medicine announced an agreement to develop and commercialize an assay for galectin-3, a biomarker that may be useful in detecting heart failure. Galectin-3 is a protein related to the initiation and progression of cardiac fibrosis and scarring, which is a leading cause of heart failure. The assay will be developed for use on Abbott’s ARCHITECT immunochemistry platform, specifically the i1000SR and i2000SR instruments. “This development and commercialization partnership with Abbott is an exciting opportunity to explore a promising diagnostic test with broad applicability in cardiovascular disease on a leading laboratory platform,” said Pieter Muntendam, MD, president and chief executive officer of BG Medicine. “BG Medicine’s strong life science discovery research program combined with Abbott’s scientific and development leadership will enable us to bring important new tests to patients and laboratories.” As part of the agreement, BG Medicine will grant a license to Abbott for intellectual property related to galectin-3. Financial terms of the agreement were not disclosed.

Asuragen Signs Distribution Agreement with Life Technologies

Asuragen announced that it has entered into an exclusive agreement with Life Technologies to develop and distribute a diagnostic test to aid in the monitoring and treatment of chronic myeloid leukemia (CML). As part of the agreement, Asuragen will seek regulatory clearance in the U.S. for the test that will be distributed by Life Technologies and run on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument, which has already received FDA 510(k) clearance. Applied Biosystems is part of Life Technologies. Asuragen’s test will detect and quantify BCR/ABL1 fusion transcripts known to exist in approximately 95% of CML and 25%–30% of acute lymphoblastic leukemia cases. “Our development of a BCR/ABL1 test leverages both our expertise in molecular diagnostics development and our proprietary Armored RNA technology,” said Rollie Carlson, PhD, president of Asuragen. “With streamlined multiplex workflow and inclusion of Armored RNA controls in the kit, the assay will have both broad target coverage and dynamic range, while offering unmatched standardization for both internal and external assay calibration.”

Clarient Granted License for Cancer Dx Biomarker

Minerva Biotechnologies has granted Clarient the exclusive right to develop and commercialize a test to identify the MUC1* protein, a biomarker researchers believe may be useful in tracking the spread of cancers. “We believe MUC1* has the potential to have an impact on cancer diagnostics,” said Ron Andrews, chief executive officer of Clarient. “It’s early in the evaluation process, but it may have significance in diagnosing, selecting therapy, and monitoring therapeutic efficacy in solid tumors. Early research has also demonstrated that MUC1* may play a role in developing resistance to cancer drugs, which means if you can block MUC1*, you may be able to overcome resistance to a drug and, once again, offer that therapy.” Clarient estimates full evaluation of the predictive value of MUC1* will take one year. The two companies will continue to collaborate on studies to validate the utility of the marker.

LabCorp Purchases Centrex Laboratories

Centrex Laboratories and Laboratory Corporation of America (LabCorp) entered into a definitive agreement under which LabCorp will acquire Centrex. Centrex will continue to operate under its name as a wholly-owned subsidiary of LabCorp with no changes made to its number of employees, core laboratory, and outpatient service centers. Centrex, a regional lab serving central New York, is currently owned by Faxton-St. Luke’s Healthcare. Following closure of the deal, Centrex will continue to be the primary lab for Faxton-St. Luke’s Healthcare and will extend services to other physicians and hospitals in the surrounding areas. “The board of directors of Centrex and the hospital view the purchase by LabCorp as an opportunity to provide a greater service to our community as well as a better position for Faxton-St. Luke’s Healthcare to weather the difficult financial road ahead,” said Joan W. Compson, chair of the board of directors of Centrex. Specific terms of the agreement were not disclosed.

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