September 2007 Clinical Laboratory News: Industry Profiles

September 2007: Volume 33, Number 9

Siemens to Acquire Yet Another Diagnostic Company

No longer only known only as an electrical engineering and electronics firm, Siemens (Munich, Germany) delivered a surprise encore of its purchase last summer of the Bayer Healthcare (Tarrytown, N.Y.) diagnostics division with the announcement of a $7 billion bid for Dade Behring (Deerfield, Ill.). “Combined, Dade Behring and Siemens will have the potential to become uniquely positioned as the largest provider of clinical diagnostic products and services in the world,” said Dade Behring CEO Jim Reid-Anderson. “We will continue to serve our clinical laboratory customers with the same care and commitment that we always have, by providing innovative products and outstanding service that meets their needs.” The deal, which marks the third big purchase by Siemens of a diagnostic firm since its acquisition of DPC (Los Angeles, Calif.) in April of last year, received approval from Dade Behring’s board, and the companies said the merger should close within 6 months.

OraSure Rapid HCV Test Hits Pre-Clinical Target

Passing a milestone on its way to becoming the first of its kind on the market, OraSure Technologies’ (Bethleham, Pa.) prototype OraQuick HCV antibody test outperformed current laboratory-based enzyme immunoassay tests using serum and plasma samples in pre-clinical studies, OraSure said. The company’s study employed 419 human subjects, as well as 639 archived HCV-positive plasma samples. OraSure reported 99.8% specificity in all specimen types, and 100% sensitivity in venous whole blood and oral fluid. The test uses oral fluid, fingerstick whole blood, venous whole blood, serum, and plasma samples. “Our development efforts are proceeding on schedule, and we intend to begin the final clinical studies required to obtain FDA approval during the next several months,” said OraSure CEO Douglas Michels. “Our plan is to complete these studies as soon as possible and file an application for FDA approval in early 2008. Assuming we are successful, we expect that our test will be the first rapid HCV antibody test approved by the FDA for use in the United States.” 

Roche Renews Bid for Ventana

With its original offer for Ventana (Tucson, Ariz.) expiring on July 26, Roche (Basel, Switzerland) said it would extend the $75 per share bid until August 23. Roche first announced the unsolicited offer at the end of June, but Ventana’s board was quick to call the offer inadequate and advised shareholders not to sell. The board maintained a hard line after Roche’s renewed bid, saying the price is still “wholly inadequate.” At press time, some 9,936 shares had been sold to Roche. 

Partnership Focuses on PGx Test for New Beta Blocker

Third Wave (Madison, Wis.) and LabCorp (Burlington, N.C.) announced a pharmacogenetics collaboration to develop a test that will help physicians personalize treatment when prescribing bucindolol, a beta blocker developed by ARCA Discovery, a privately-held company based in Denver, Colo. The new test identifies common genetic variations in the alpha-2c and beta-1 adrenergic receptors that affect patient response to bucindolol. ARCA plans to include genetic data on targeting patients who are most likely to respond to the drug in its application for FDA approval. “Third Wave is pleased to collaborate with LabCorp on the development of this groundbreaking companion molecular test,” said Third Wave CEO Kevin Conroy. “We hope our collaboration with LabCorp is a new model for the development and application of personalized drug therapies. We believe it will demonstrate the impact clinical reference laboratories, diagnostic manufacturers, and pharmaceutical companies can have when working together to positively affect patient outcomes and impact healthcare costs.”

Affymetrix, Partners Healthcare Team Up on PGx Tests

Under a new contract array manufacturing (CAM) agreement, Affymetrix (Santa Clara, Calif.) will create custom microarrays based on data from recent discoveries made by Partners Healthcare (Boston, Mass.) researchers. Partners Healthcare will use the arrays to develop molecular pharmacogenomic tests for hypertrophic cardiomyopathy and other indications in a number of diseases. Partners Healthcare will then validate and implement the new tests in its CLIA labs. “The collaboration with Affymetrix allows us to bring complex genetic and genomic testing into clinical practice, helping physicians make appropriate clinical decisions,” said Raju Kucherlapati, scientific director of Harvard Medical School-Partners HealthCare Center for Genetic and Genomics (HPCGG, Cambridge, Mass.). “Affymetrix’ GeneChip technologies enable us to bring complex genomic tests in a cost-effective manner to the patients.” The new agreement builds on a collaboration begun in September, 2006 among Affymetrix, Harvard Medical School (Boston, Mass.), Partners Healthcare, and HPCGG that used Affymetrix chips to look for genetic sequences associated with complex diseases.

Final Terms Foil GE, Abbott Deal

Though they remained reticent about details, GE (Fairfield, Conn.) and Abbott (Abbott Park, Ill.) said they were unable to agree on final terms and conditions, thereby terminating GE’s $8.13 billion agreement to purchase Abbott’s core diagnostic businesses. A mutual decision was made not to go forward with the sale due to the complexity of the transaction and difficulties resolving the way in which the businesses would be separated, the companies said. In an investor Web cast, Abbott executives remained upbeat despite the collapse of the sale, and said the company is now committed to its diagnostic business for the long term.


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