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February 2011 Clinical Laboratory News: Industry Profiles

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Gen-Probe Purchases GTI Diagnostics

Gen-Probe has acquired GTI Diagnostics, a privately held diagnostics firm focused on the transplant, blood banking, and specialty coagulation markets, for $53 million. According to Gen-Probe, the acquisition will expand the company’s diagnostic portfolio and offer new growth opportunities in the blood bank and specialty coagulation markets. “In addition, the acquisition gives us access to growing coagulation and transfusion-related blood bank products that we can sell to our current customer base,” said Carl Hull, Gen-Probe’s president and CEO.

GE Healthcare Completes Initial Offering Period for Clarient

GE Healthcare announced that it has completed a tender offer for all outstanding shares of common and preferred stock of Clarient. GE Healthcare said that its diagnostic imaging combined with Clarient’s technologies will speed development of integrated tools for cancer diagnosis and characterization. “Adding Clarient’s leading technology to our portfolio will accelerate our expansion into cancer diagnostics and therapy selection tools, while strongly enhancing our current diagnostic and life sciences offerings,” said John Dineen, CEO of GE Healthcare.

DiaGenic and Pfizer Ink Agreement for Alzheimer’s Biomarker Discovery

DiaGenic and Pfizer have signed a deal in which DiaGenic will use its gene expression technology and blood samples from ongoing clinical studies to identify biomarkers of early-stage Alzheimer’s disease for Pfizer. Pfizer will be granted a non-exclusive, worldwide license to use DiaGenic’s MCI test and Alzheimer’s test in its research and development programs. “MCI progression biomarkers will be very useful in drug discovery, in clinical trials as surrogate markers of treatment efficacy, as well as being very valuable as diagnostic tests in clinical practice,” said DiaGenic CEO Erik Christensen.

Court Rules in Favor of Patents for Diagnostic Tests

The Court of Appeals for the Federal Circuit in Washington has ruled that diagnostic tests used to measure whether a patient is getting the proper dose of a medicine are patentable. The ruling, which upheld patents owned by Prometheus Laboratories, was an important victory for companies that want to develop and patent companion diagnostic tests designed to determine whether patients are receiving appropriate dosages. The suit stems from a 2008 case in which Prometheus sued the Mayo Clinic, which wanted to offer a competing test in its reference laboratory. A lower court agreed with Mayo that Prometheus’s patents were invalid because the test involved merely gathering data and observing natural phenomena. The appeals court, however, reversed the decision by ruling that Prometheus’s tests met the court’s “machine-or-transformation” requirement.

AltheaDx and Compendia Team Up to Develop Breast Cancer Assay

AltheaDx has announced the formation of a strategic alliance with Compendia Bioscience that will combine their technologies to develop tests that can predict patient outcomes in clinical trials. The initial product developed under the partnership is the Breast Cancer Segregation Panel Assay. The test is a real-time, PCR-based panel that has been optimized for analysis of RNA extracted from formalin-fixed, paraffin-embedded tissue. The panel includes 96 genes associated with breast cancer identified through a meta-analysis of cancer genomic data from more than 5,000 clinical samples.

Akonni Wins NSF Grant to Test Microarrays Manufacturing Method

Akonni Biosystems has received a $150,000 National Science Foundation grant to evaluate a method of manufacturing microarrays that could dramatically lower the cost of conducting molecular diagnostic testing in the future. The molecular diagnostic firm will use the grant to assess lab-on-a-film microarray manufacturing and assembly methods. Akonni referenced market research to conclude that the number of molecular and genetics tests performed in the U.S. is expected to reach 80 million by next year. According to the firm, as those numbers climb and budgets tighten, the next technological revolutions in molecular diagnostics will have to result in substantial cost savings.

Luminex and One Lambda Renew Long-Term Strategic Alliance

Luminex announced it has renewed its strategic long-term partnership with One Lambda. The alliance, which began in 2000, has resulted in the development of new products that help healthcare providers better match organ donors with recipients. As a result, their collaborative efforts have made pre- and post-transplant diagnostics faster and more cost-efficient. “One Lambda and Luminex combined the power of Luminex’s xMAP Technology with One Lambda’s expertise in HLA testing and organ transplantation to dramatically advance the care available to those undergoing transplants,” said George Ayoub, president and CEO of One Lambda.

Myriad Genetics Acquires Melanoma’s Diagnostic Technology

Myriad Genetics Laboratories announced it will acquire technology from Melanoma Diagnostics for the diagnosis and prognosis of malignant melanoma using genetic markers. Under the terms of the agreement, Myriad has the global right to commercialize all tests based on the technology. According to Mark Capone, president of Myriad Genetics, the tests developed from the deal may allow doctors to differentiate melanoma from other benign moles and to understand the aggressiveness of a patient’s disease.

Court Dismisses Patent Infringement Lawsuits Against Affymetrix

A U.S. federal court has dismissed two lawsuits filed by Illumina alleging that Affymetrix infringed on patents Illumina holds covering array technologies. The judge ruled that Affymetrix’s GeneChip and GeneTitan products—the subjects of Illumina’s lawsuits—did not include a substrate, and so cannot infringe on the patents in dispute. Rick Runkel, Affymetrix’s executive vice president, secretary, and general counsel, said that the decision by the court affirms the company’s position that the lawsuits were without merit.