American Association for Clinical Chemistry
Better health through laboratory medicine
June 2009 Clinical Laboratory News: Industry Profiles

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June 2009: Volume 35, Number 6

Roche Buys Genentech

Swiss giant Roche completed its acquisition of California-based Genentech in which Genentech became a wholly-owned member of the Roche Group on March 26. In connection with the merger, all remaining public shareholders will receive $95 per share for their shares, a price that will cost Roche approximately $46.8 billion to purchase the remaining 44% of the company Roche did not already own. In the merger Roche will obtain rights to a large line of products and biomarkers, including Herceptin.

Quest Agrees to Pay Fine for Misbranding Tests 

First-ever consensus guidelines on quantitative PCR aim to improve the quality and transparency of studies involving qPCR (Clin Chem, 2009;55:611-622). The Minimum Information for Publication of Quantitative Real-Time PCR Experiments (MIQE) guidelines outline the minimum information necessary to evaluate qPCR studies, including all relevant experimental conditions and assay characteristics, and full disclosure of all reagents, sequences, and analysis methods. The guidelines include an 85-item checklist of desirable and essential steps to be followed when using qPCR and information to be divulged from experiments involving qPCR. The purpose of the guideline is to encourage better experimental practice, so as to enable more reliable and unequivocal interpretation of qPCR results.

Use of qPCR has proliferated, yet studies “invariably use diverse reagents, protocols, analysis methods, and reporting methods,” the authors wrote. “This remarkable lack of consensus on how best to perform qPCR experiments has the adverse consequence of perpetuating a string of serious shortcomings that encumber its status as an independent yardstick.” If researchers follow the guidelines, they should be able to design and report qPCR experiments with greater inherent value, and fellow researchers, editors, and laboratorians should be able to evaluate the technical quality of the published data against an established standard.

Rosetta to Collaborate with Prometheus on Diagnostics Tests 

Rosetta Genomics signed a license and collaboration agreement with Prometheus Laboratories for the exclusive U.S. rights to three of Rosetta’s new microRNA-based cancer diagnostic tests: miRview mets, miRview squamous, and miRview meso. Prometheus agreed to pay Rosetta milestone payments, provide research and development funding, pay royalties on net sales in the U.S., and invest $8 million in Rosetta for about 14% of the company. Prometheus and Rosetta also agreed to develop two new microRNA-based gastroenterology tests, which may result in additional payments to Rosetta. Funding for these tests will be provided by Prometheus. "We believe that with this agreement Rosetta has proven the great commercial value of its first three products, and has established itself as a leader in the development of novel, molecular diagnostic products based on microRNAs," said Amir Avniel, president and CEO of Rosetta Genomics. "With Prometheus these tests now will be available across the U.S., and will be supported by an organization with a proven ability in diagnostic testing services and in launching new products."

Abraxis Invests in Expression Pathology 

Expression Pathology, a developer of technology for analyzing biomarkers in tissue, received $6.5 million in financing from biopharmaceutical firm Abraxis Bioscience. Expression Pathology intends to use the funds to apply its patented Liquid Tissue proteomics technology in developing personalized clinical assays for the measurement of protein biomarkers of drug response and disease prognosis. Casey Eitner, president and CEO of Expression Pathology, said, “We believe the ability of our technology to interrogate archived tissue collections to discover and validate protein biomarkers that relate to disease progression, drug response and toxicity, and to measure those biomarkers accurately in standard tissue from clinical trials and medical care, will translate into a tremendously valuable asset.”