American Association for Clinical Chemistry
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March 2010 Clinical Laboratory News: Industry Profiles

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March 2010: Volume 36, Number 3

OraSure Technologies, Roche Sign Commercialization Agreement

OraSure Technologies and Roche Diagnostics announced that the two companies have signed an agreement for worldwide commercialization of fully automated, oral fluid, drugs-of-abuse assays using OraSure’s Intercept oral specimen collection device. The Intercept device is the only FDA-cleared, laboratory-based, oral fluid testing system used for detecting commonly abused drugs such as marijuana, cocaine, opiates, PCP, amphetamines, barbiturates, methadone, and benzodiazepines. The assays use Roche’s KIMS technology and will be jointly developed by both companies.

“We are very pleased with our joint development effort with Roche and the finalization and execution of the commercialization agreement associated with these important drugs-of-abuse assays,” said Douglas A. Michels, president and chief executive officer of OraSure Technologies. “We look forward to working with Roche to bring these new assays to market where they will have an immediate and positive impact on laboratory efficiency for drugs-of-abuse testing.” The commercialization agreement is structured to capitalize on Orasure’s established presence in the oral fluid testing market, and Roche’s established base of analyzers and marketing capabilities. Additional terms of the agreement were not disclosed.

Quidel Announces Acquisition of Diagnostic Hybrids

Quidel announced the signing of a definitive agreement to acquire Diagnostic Hybrids, a manufacturer of direct fluorescent in vitro diagnostic assays used in hospitals and reference labs, for approximately $130 million in cash. “Our combined organization will have greater channel strength, and together we will provide our customers a full service offering the best-in-class diagnostic products,” said David Scholl, PhD, president and chief executive officer of Diagnostic Hybrids. Quidel plans to operate Diagnostic Hybrids as a separate subsidiary. Dr. Scholl will remain as president of Diagnostic Hybrids and also become a senior vice president of Quidel. The acquisition is subject to customary closing conditions and is expected to close in the first quarter of 2010.

Life Technologies to Buy AcroMetrix

Life Technologies announced that it has signed a definitive agreement to acquire AcroMetrix, a provider of molecular and serological diagnostic quality control products used by clinical laboratories, blood screening centers, and in vitro diagnostic manufacturers. “With the growth of DNA and other molecular based tests, there is a growing need for high-quality, independently provided controls to ensure the accuracy and integrity of laboratory test results,” said Gregory T. Lucier, chairman and chief executive officer of Life Technologies. “The acquisition of AcroMetrix builds on our substantial business of providing tools and technologies into the molecular diagnostics industry.” Financial terms of the agreement were not disclosed.

Predictive Biosciences to Acquire OncoDiagnostic Laboratory

Predictive Biosciences announced the acquisition of OncoDiagnostic Laboratory (ODL), a private, CLIA-certified anatomic and molecular diagnostics lab serving specialty physicians. The acquisition provides Predictive Biosciences with a fully integrated pathology laboratory through which the company plans to commercialize its molecular cancer diagnostic assays. The first in Predictive Biosciences’ portfolio of non-invasive assays is a urine biomarker-based test for the detection of bladder cancer, which the company plans to make commercially available in 2010. “We look forward to leveraging ODL’s urology focused sales organization to introduce our proprietary bladder cancer assay later this year,” said Peter Klemm, PhD, president and chief executive officer of Predictive Biosciences. “Importantly, Predictive and ODL share a common set of values—a commitment to innovation, customer service, and patient care—and we are certain that these values will serve as a solid foundation for our merged company’s growth.” Financial terms of the agreement were not disclosed.

AstraZeneca, Dako to Collaborate on Personalized Medicine

AstraZeneca and Dako Denmark A/S announced that they have entered into a collaborative agreement to develop companion diagnostic tests for multiple AstraZeneca oncology projects. Under the agreement, the companies will work to develop diagnostic tests that can be used by physicians to determine the most appropriate cancer treatments. The collaboration will combine Dako’s expertise in cancer diagnostics and AstraZeneca’s experience in the development and commercialization of oncology products. “We believe it is important for pharmaceutical and diagnostic companies to combine their expertise in a strong, collaborative approach to enable the development of diagnostic tests for use with drug therapies,” said Lars Holmkvist, chief executive officer of Dako Denmark A/S. The financial terms of the agreement were not disclosed.