December 2010 Clinical Laboratory News: Industry Profiles

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Qiagen, Abbott Ink Molecular Diagnostics Deal

Qiagen and Abbott have entered into a molecular diagnostics pact that includes tests for Human Immunodeficiency Virus (HIV), human papillomavirus, and hepatitis C virus (HCV). Under the terms of the agreement, Qiagen will receive kits from Abbott for a polymerase chain reaction (PCR)-based molecular assay for HIV-1 viral load testing in the U.S. and Canada to be commercialized under QIAGEN's brand. The new HIV-1 test is expected to be available by 2012. Qiagen, in return, will supply Abbott with certain key products required for a PCR-based human papillomavirus test in the U.S. and Canada. Abbott will also provide a quantitative hepatitis C virus test, which will be optimized and labeled for use on Qiagen's QIAsymphony RGQ instrument and marketed under the Abbott name in the U.S. and Canada. The HCV test is subject to regulatory approval and may become available by the end of 2012.

Roche, German Cancer Research Center to Develop Dx for Cervical Cancer

Roche Molecular Systems and the German Cancer Research Center have announced plans to work together on research aimed at improving the ability to predict a woman’s risk for developing cervical cancer. The research is based on the German Center's research on RNA markers and will be conducted using Roche's proprietary systems, including the cobas 4800 System. According to Roche, the Center’s preliminary results indicate that the relative amounts of specific spliced viral RNA molecules in human papillomavirus-infected cells can be used for the highly accurate discrimination of cervical cancer and high-grade from low-grade cervical lesions.

GE Healthcare to Purchase Clarient for $580M

GE Healthcare announced it will acquire Clarient, a molecular diagnostics and imaging firm, for around $580 million. Clarient is in the process of developing proprietary biomarkers and tests for profiling breast, prostate, lung, colon, and blood-based cancers. GE Healthcare said the acquisition will strongly enhance the company’s current diagnostic and life science offerings, as well as speed up development of new integrated tools for diagnosis and characterization of cancer.

Roche Signs Agreement to Acquire RALS IT Assets

Roche Diagnostics and Medical Automation Systems, Inc., (MAS) have inked a deal in which Roche will obtain all the assets associated with the RALS point-of-information technology (IT) connectivity system, as well as the names “Medical Automation Systems,” “MAS” and “RALS.” According to Roche, the acquisition is aimed at both strengthening the company’s presence in point-of-care information management, and building on its strategy to deliver integrated testing solutions. “The acquisition of RALS assets is a perfect fit with our strategy to deliver market-leading IT connectivity solutions. It further complements our IT product portfolio,” said Peter Finckh, head of Global Platforms and Support at Roche Diagnostics. 

bioMérieux, Biocartis Ink Molecular Diagnostics Agreement

bioMérieux and Biocartis have signed a strategic deal to co-develop and co-distribute assays on Biocartis’ molecular diagnostics platform. As part of the agreement, bioMérieux will be granted worldwide exclusive rights to develop and commercialize microbiology assays on Biocartis’ platform. The firm will also have access to the platform for certain oncology and theranostics assays. Additionally, bioMérieux is taking a $12.8 million equity stake in Biocartis. The firms plan to co-distribute the assays next year.

Cepheid, Novartis Join Forces to Launch Leukemia Test

Cepheid and Novartis have teamed up to commercialize a molecular diagnostic test for Philadelphia chromosome-positive chronic myelogenous leukemia, or Ph+CML. The Xpert BCR-ABL test is based on Cepheid’s GeneXpert system. The test has been available for sale outside the U.S. since 2006. The deal is expected to speed up efforts to receive FDA clearance for commercial launch of the leukemia test in the U.S.

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