American Association for Clinical Chemistry
Better health through laboratory medicine
May 2008 Clinical Laboratory News: Industry Profiles

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May 2008: Volume 34, Number 5

LabCorp Developing MGMT Methylation Testing Service

LabCorp announced an agreement to license intellectual property from OncoMethylome to offer MGMT methylation testing services. MGMT methylation status has been shown to be a potential predictor of response to alkylating agent-based chemotherapies used to treat patients with malignant brain tumors. LabCorp will perform MGMT methylation status testing using methylation-specific PCR technology licensed from OncoMethylome. “This test is aligned with our focus on companion diagnostics, and we are excited by the potential of the MGMT methylation test to help oncologists provide better patient care and guide therapy decisions,” said Myla Lai-Goldman, MD, Executive Vice President, Medical Director and Chief Scientific Officer of LabCorp. “Laboratory tests for gene methylation are an important and differentiating addition to our menu of oncology services and allow us to offer a more complete package of services to oncologists and their patients.” Terms of the licensing agreement include an undisclosed upfront fee, milestone payments, and royalties from LabCorp.

AcroMetrix Inks Deal with Beckman Coulter for Molecular QC Standards

AcroMetrix announced an agreement with Beckman Coulter for the development and supply of molecular quality control standards for various molecular targets. The agreement includes an initial development and supply of QC standards for 10 molecular targets that will be used in the development of Beckman Coulter’s molecular UniCel DxN instrument. “This deal demonstrates the importance of quality control and standardization in molecular diagnostic testing,” said Michael Eck, CEO of AcroMetrix. Financial terms were not disclosed.

Metabolon and Harvard-Partners Center to Work on Warfarin Dosing

Metabolon, Inc. and the Harvard-Partners Center for Genetics and Genomics (HPCGG) announced an agreement to develop an improved diagnostic test for accurate warfarin dosing. HPCGG investigators will use Metabolon’s biochemical profiling platform that provides for the extraction, identification, and quantitation of small molecules in biological samples. The research will look into whether a patient’s metabolomic profile might increase the likelihood of dosing warfarin correctly. Patient samples for the study are being collected as part of the ongoing Partners HealthCare “CReating an Optimal Warfarin Nomogram” (CROWN), a prospective dosing study using genetic testing to determine optimal warfarin dosing. “If we can improve the accuracy of warfarin dosing by our clinicians, even by modest percentages, we will increase the likelihood that patients will respond to therapy, and ultimately we will reduce serious medical complications of therapy,” said Raju Kucherlapati, PhD, director of HPCGG. “Metabolon’s biomarker discovery platform gives us the opportunity to find biochemical markers that, along with genetic variations, might help characterize the differences between patients’ metabolism of warfarin.” Financial terms of the collaboration were not disclosed.

Fujirebio Acquires American Biological Technologies

Fujirebio Diagnostics announced the acquisition of American Biological Technologies, a Texas-based manufacturer of in vitro diagnostic assay controls and calibrators and a long-term main supplier to Fujirebio. The merger marks Fujirebio’s entry into the controls and calibrators manufacturing business. “For more than 20 years, Fujirebio Diagnostics has been on the forefront of oncology diagnostics, bringing to market vital biomarker assays that enable clinicians to better manage cancer,” said Paul Touhey, Fujirebio CEO. “The acquisition is a natural next step on our path in entering diagnostic assay control and manufacturing and mirrors Fujirebio Diagnostics’ strategy to provide its diagnostic industry customers with the tools and services that will revolutionize how disease is diagnosed and managed.” With the union of the two companies, both new and existing industry customers will benefit from enhanced, streamlined delivery of material used in products sold to laboratory customers, the company said. Financial terms were not disclosed.

Vermillion Licenses PAD Biomarker Panel from Stanford University

Vermillion announced an exclusive licensing agreement with Stanford University to develop and commercialize a novel biomarker panel used to assess the risk of peripheral artery disease (PAD). In collaboration with Stanford, Vermillion completed a 540-patient clinical study— which they intend to publish soon—evaluating the ability of the biomarker panel to classify people as either high or low risk for PAD,. “PAD is underdiagnosed and undertreated. We need new, innovative tools to aid in the diagnosis and management of this life- and limb-threatening disease,” said John Cooke, MD, PhD, Professor of Medicine at Stanford University. His research formed the basis for the PAD blood test. “Through our successful venture with Vermillion, we are working to develop the essential tools to improve diagnosis, with the intent of expediting treatment and enhancing patient outcomes.” Financial terms of the licensing agreement were not disclosed.

Raven and Monogram Team Up on Cancer Diagnostics

Raven Biotechnologies announced an agreement with Monogram Biosciences under which Monogram will evaluate Raven monoclonal antibodies for use with Monogram’s VeraTag technology for cancer diagnostics. Monogram markets its VeraTag technology for the development of targeted drugs, for improving clinical trials, and predicting patient responses to drugs. “Raven’s extensive library of antibody candidates that bind to antigens present at high levels on tumor tissue can be developed as therapeutic and diagnostic antibodies,” said George Schreiner, MD, PhD, CEO of Raven Biotechnologies. Financial terms of the deal were not disclosed.

Beckman Coulter, Immune Tolerance Network Launch Collaboration

Joining forces to integrate genomic, cellular, proteomic, and bioinformatic technology platforms to understand immune-related diseases, Beckman Coulter and the non-profit Immune Tolerance Institute (ITI) announced a collaboration to create a Center for Critical Path Immunology that will work to develop novel biomarkers for new drugs and companion diagnostics. “Advancing ‘critical path’ science will lead to new approaches to investigate the biological mechanisms of disease and to better predict the clinical efficacy and safety of emerging therapeutics,” said Wade Bolton, PhD, VP of Custom BioPharma Solutions and Services at Beckman Coulter. “Working with ITI and their distinguished staff, we will be able to identify new solutions and make them available for better patient management.”