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March 2011 Clinical Laboratory News: Industry Profiles

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Danaher to Buy Beckman Coulter

Beckman Coulter and Danaher have inked a definitive merger deal under which Danaher will obtain all of Beckman Coulter’s outstanding common stock for $83.50 per share in cash, representing an approximate 45% premium over the closing price of Beckman Coulter’s common stock on December 9, 2010. The deal is valued at approximately $6.8 billion, and is set to be completed by the first half of 2011. “Longer term, we will have significant opportunities to leverage our relationships across our large installed base of automated systems in hospital laboratories with that of Danaher,” said Bob Hurley, president and CEO of Beckman. Beckman Coulter will become part of Danaher’s Life Sciences and Diagnostics segment, joining its Leica, AB Sciex, Radiometer, and Molecular Devices businesses. Beckman Coulter announced in December that the company was up for sale following controversy surrounding its AccuTnI test kits run on the UniCel Dxl immunoassay system and the resignation of president Scott Garrett.

Hopkins to Construct Center for Personalized Medicine Research

Johns Hopkins University announced that its Whiting School of Engineering will use a $30 million gift to build a 56,000-square-foot facility that will house personalized medicine programs. The new building will be called Malone Hall, and bring together engineers, life scientists, and medical researchers from across the university in an effort to integrate information science into the practice of medicine. The initial focus will be on cancer. “The approach grows out of the recognition that genetic and epigenetic differences among patients explain, at least in part, why traditionally developed drugs help some people and not others,” said school officials.

Novartis Buys Personalized Diagnostics Services Firm Genoptix

Novartis has signed a definitive deal to purchase Genoptix for approximately $470 million. The purchase will provide Novartis with a lab testing services business that focuses on cancers of the blood and solid tumors. “The acquisition of the Genoptix medical laboratory will serve as a strong foundation for our individualized treatment programs,” said Joseph Jimenez, Novartis’ CEO.

Biocartis Inks Molecular Assay Development Deal

Biocartis has signed a strategic deal with Janssen Pharmaceutica, part of Johnson & Johnson’s Janssen Pharmaceutical division, to co-develop assays on Biocartis’ fully integrated molecular diagnostics system. Under the terms of the deal, Janssen and J&J’s Ortho-Clinical Diagnostics group will be given worldwide exclusive rights to develop and commercialize assays on the Biocartis platform in the fields of neurological disease and certain viral infectious diseases. “This second major collaboration further expands and accelerates our plans to develop a broad and clinically relevant menu of molecular diagnostic tests on our unique integrated platform,” said Rudi Pauwels, founder and CEO of Biocartis.

Beckman Coulter, Transgene to Develop Companion Dx Test for TG4010

Beckman Coulter announced it plans to develop a companion diagnostic for Transgene to measure levels of activated Natural Killer (aKN) cells, in order to select patients to be treated with TG4010, an MVA-MUC1-IL2 immunotherapy candidate that is about to enter a Phase IIb/III clinical trial. Beckman Coulter will develop the companion test to measure triple positive—CD16+, CD56+, CD69+/CD45+ lymphocytes—aNK cells to identify patients who may be suitable for treatment with TG4010.

NanoString Eyes Expansion into Molecular Diagnostics Market

NanoString Technologies announced that it plans to expand into the molecular diagnostics sector. The company’s first diagnostic test will be based on the PAM50 gene signature for breast cancer. “So we are naturally building a diagnostic strategy around oncology gene signatures in the clinic,” said Brad Gray, president and CEO of NanoString. “The overall vision is to become the platform of choice for FDA-approved, in vitro diagnostic tests that are based on multiplex gene expression profiling in cancer.”

Opko Health, Bristol-Myers Squibb Collaborate on Alzheimer’s Blood Test

Opko Health has signed an agreement with Bristol-Myers Squibb to co-develop a blood test for Alzheimer’s disease. Under the terms of the deal, Opko Health will work with the pharmaceutical giant to examine the utility of its technology in diagnosing Alzheimer’s disease and identifying individuals with early-stage cognitive impairment that are likely to progress to Alzheimer’s disease.

Foundation Medicine, Novartis Collaborate on Cancer Diagnostics

Foundation Medicine, Inc. announced a strategic pilot partnership with Novartis to develop, improve, and optimize Foundation Medicine’s cancer genome panel test. “This pilot collaboration with Novartis represents our first pharmaceutical partnership, and we are delighted to accomplish this important milestone with one of the world’s leading cancer therapeutic companies,” said Alexis Borisy, CEO of Foundation Medicine. The two companies will evaluate opportunities to commercialize the test if the pilot phase is successful.

IMDx to Develop Assays on Abbott’s m2000 Platform

IMDx, a molecular diagnostics firm, has signed a deal with Abbott to design, develop, and manufacture tests using Abbott’s FDA-approved m2000 platform. The tests covered by the deal include assays for Clostridium difficile, vancomycin-resistant Enterococci; Group B Streptococci; Influenza A/Influenza B, and Herpes simplex virus types 1 and 2.

Cepheid and FIND Team Up to Develop HIV Viral Load Test

Cepheid and the Foundation for Innovative New Diagnostics announced a new partnership to speed up the development of a rapid molecular test for the measurement of human immunodeficiency virus (HIV) viral load. As a result of the collaboration, the Xpert HIV viral load test, which will run on Cepheid’s GeneXpert platform, is expected to complement the Xpert MTB/RIF test for tuberculosis (TB) and drug-resistance. The deal is also designed to deliver the benefits of rapid and accurate molecular testing for TB, HIV, and sexually transmitted diseases using a single instrument in some of the most challenging geographies across the globe.

XDx and LabCorp Ink Deal to Expand Molecular Expression Tests

XDx, Inc., a molecular diagnostics firm, has signed a multi-year deal with Laboratory Corporation of America Holdings to provide the firm’s AlloMap test in the U.S. Under the agreement, the AlloMap test, which is the only non-invasive gene expression test to help physicians identify the absence of heart transplant rejection, will be offered to eligible heart transplant patients. This expanded deal follows a successful one-year pilot program between the companies at select LabCorp blood draw sites.