American Association for Clinical Chemistry
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January 2011 Clinical Laboratory News: Industry Profiles

Industry Profiles

Beckman Coulter Puts Itself Up for Sale

Executives at Beckman Coulter have put the company up for sale after receiving buyout approaches from undisclosed firms. Goldman Sachs will act as the adviser for the sale. With its debt load, the company has an enterprise value of about $5 billion. The reported sale comes amid an unsettled period for the company including the unexpected resignation of its chairman and chief executive, Scott Garrett, last September.

Roche’s Restructuring Affects Diagnostics Division

Roche announced a global restructuring plan that will affect 4,800 jobs worldwide, including 640 positions in the company’s diagnostics division. The cuts will come primarily from the firm’s molecular tools and molecular diagnostics operations, as well as the blood gas diagnostics and diabetes care products divisions. “This is a comprehensive, focused initiative to reinforce Roche’s long-term innovation capability in the face of increased price pressures and a more challenging market environment,” said Roche Group CEO Severin Schwan. The company’s restructuring effort is a response to mounting cost pressures in healthcare, according to Roche.

LabCorp Concludes Acquisition of Genzyme

Laboratory Corporation of America announced that it has successfully completed its purchase of Genzyme Genetics’s testing unit for $925 million. The deal, announced in September 2010, includes all of Genzyme Genetics’s testing services, technology, intellectual property rights, and nine testing laboratories. “Closing the acquisition of Genzyme Genetics firmly establishes LabCorp as the premier genetics and oncology laboratory in the United States and further strengthens LabCorp’s leadership position in personalized medicine,” said David King, chairman and CEO of LabCorp.

SIRS-Lab, Pfizer Collaborate on Sepsis MDx

SIRS-Lab announced it will partner with Pfizer Pharma on sepsis diagnostics and treatment.The firms will first focus on evaluating the clinical impact of using molecular-based tests for diagnosis of severe fungal blood stream infections, as well as the pharmacoeconomics of such an approach.

Epigenomics and Predictive Biosciences Extend Licensing Deal on Prostate Cancer Dx

Epigenomics AG and Predictive Biosciences announced that the companies will extend a licensing agreement under which Predictive Biosciences is developing a prostate cancer test using the GSTP1 biomarker. The deal, originally inked in April 2009, granted Predictive Biosciences exclusive rights to develop a prostate cancer test incorporating the DNA methylation biomarker and an option to license GSTP1 for commercialization as a laboratory service in the U.S. Predictive Biosciences has decided to execute this option and plans to commercialize the test in the future. In return, Epigenomics will receive a one-time payment.

Roche and CapitalBio to Collaborate on MDx Applications

Roche Diagnostics has inked a memorandum of understanding for a strategic alliance with CapitalBio aimed at developing molecular diagnostics applications and technologies. According to Roche, the collaboration is designed to further development of microarray technologies and complementary molecular products. Initially, Roche will concentrate on improving and automating the company’s NimbleGen microarray workflow for preventive and personalized diagnostics.

OraSure’s Rapid HCV Test Receives Popular Science Award

OraSure Technologies’ rapid HCV (Hepatitis C) test was honored as one of the top technology innovations of 2010 by Popular Science magazine. As a winner of a “Best of What’s New” award, the OraQuick HCV Rapid Antibody Test was praised for its technology and for being the first-ever rapid, point-of-care test approved by the FDA for the detection of antibodies to HCV.

Roche to Develop Test and Companion Dx to Treat Lung Cancer

Roche Diagnostics has received worldwide rights from Genzyme to develop a test that can detect epidermal growth-factor receptor (EGFR) mutations involved in some types of lung cancer. The test will also be able to predict a patient response to Roche’s lung cancer drug, Tarceva. Roche also announced that it will partner with OSI Pharmaceuticals to develop the companion diagnostic, which Roche intends to use on its cobas 4800 system. The PCR-based companion diagnostic test will identify patients with non-small cell lung cancer who carry EGFR activating mutations.

Insight Genetics to Develop New Lung Cancer Test with NCI Contract

Insight Genetics announced it will use a $200,000 Phase I Small Business Innovation Research contract from the National Cancer Institute to develop a new lung cancer test. Insight Genetics was one of four companies in the nation to be selected to receive funding, which was awarded as part of a solicitation titled “Companion Diagnostics: Predictive and Prognostic Tests Enabling Personalized Medicine in Cancer Therapy.” The company will use the NCI contract to further validate its Insight ALK Screen, a real-time PCR-based test that detects cancer-causing fusions and mutations of anaplastic lymphoma kinase.

MDxHealth, Predictive Bio to Develop Bladder Cancer Dx Test

MDxHealth and Predictive Biosciences have teamed to develop a bladder cancer test. Under the agreement, MDxHealth licensed certain DNA methylation biomarkers to Predictive Biosciences to develop the test. The deal grants Predictive Biosciences exclusive rights in the U.S. to use the biomarkers to develop the test, for which Predictive will pay MDxHealth upfront and milestone payments, as well as royalties on net sales.

BRL Collaborates with Mass General on PGx Tests

Bio-Reference Laboratories has inked a definitive deal with Massachusetts General Hospital to develop pharmacogenomic tests for cancer. The partnership will use a solid tumor genotyping and pharmacogenomics testing platform developed by Massachusetts General. The platform will allow the simultaneous assessment of more than 100 cancer mutations in clinical tumor specimens, which will allow for better selection of targeted treatments for each patient.