September 2009 Clinical Laboratory News: Industry Profiles

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September 2009: Volume 35, Number 9

Data Innovations Acquires David G. Rhoads Associates

Data Innovations announced that it has acquired David G. Rhoads Associates, a developer of quality assurance, statistical analysis, and laboratory management software for clinical labs. Under the agreement, Data Innovations will acquire 100% of the equity interests of Rhoads. Rhoads currently has over 2,500 copies of its EP Evaluator software in use worldwide that is targeted to the same market as Data Innovations’ middleware products, Instrument Manager and Laboratory Production Manager, although they offer distinct and complementary features. Hunter Bagwell, sales and marketing manager of Data Innovations, stated, “We strive to offer our customers the most comprehensive solutions to increase efficiency and improve workflow, and the addition of EP Evaluator to our portfolio shows that commitment.” Financial terms of the agreement were not disclosed.

Abbott, GSK to Begin Work on Cancer Antigen Test

Abbott announced that it has entered into an agreement with GlaxoSmithKline (GSK) to develop an automated molecular diagnostic test based on PCR technology to screen non-small cell lung cancer (NSCLC) tumors for the expression of the MAGE-A3 antigen. Under the terms of the agreement, Abbot and GSK will develop and commercialize a PCR test designed to detect MAGE-A3 for use on the Abbott m2000 automated instrument system. Currently there are no nucleic acid-based tests approved by FDA for use in identifying patients who may benefit from treatments targeting NSCLC. Vincent Brichard, MD, PhD, vice president and head of immunotherapies at GSK, stated, “Through this partnership we aim to make MAGE-A3 testing of lung tumors available in standard pathology labs around the world. This means patients globally could be able to find out if they are eligible and can potentially benefit from targeted cancer treatment against this antigen.”

DxS, AstraZeneca to Collaborate on Diagnostic for IRESSA

DxS announced that it is working closely with AstraZeneca to make available a companion diagnostic for use with IRESSA, AstraZeneca’s treatment for non-small cell lung cancer (NSCLC). DxS’ clinical diagnostic, the TheraScreen: EGFR29 Mutation Kit will be used to test the status of a patient’s epidermal growth factor receptor (EGFR) oncogene to identify their eligibility for treatment with IRESSA. The kit is based on DxS’ ARMS and Scorpions PCR technology that can detect low levels of mutant DNA in tumors in less than 3 hours. IRESSA works by inhibiting the tyrosine kinase enzyme in the EGFR, blocking signals involved in the growth and spread of tumor cells. In approximately 10 to 15% of NSCLC cases in Caucasians, a mutation in the EGFR pathway causes tumors to be especially susceptible to IRESSA treatment.

Beckman Coulter Buys Olympus Diagnostics Division

Beckman Coulter completed the acquisition of Olympus’ lab-based diagnostics business for approximately $780 million in cash. “The completion of this transaction adds considerable product depth and significantly expands our geographic reach and scale. We are confident that the combination of Olympus diagnostics with our business will provide many cross-selling opportunities—the most compelling being Beckman Coulter’s leading immunoassay products to the loyal base of Olympus’ chemistry customers,” said Scott Garrett, chairman, president, and CEO of Beckman Coulter. The company expects to provide additional details about the impact of the transaction on labs during the company’s third quarter earnings news release in late October.

Enigma Diagnostics Signs Patent Licenses with Roche

Enigma Diagnostics signed two patent licenses with Roche Molecular Systems, providing Enigma full access to practice HybProbe real-time PCR chemistry and melt analysis. The agreement will allow Enigma to commercialize HybProbe PCR tests for human and veterinary in vitro diagnostics worldwide. Enigma is currently developing a series of highly multiplexed, HybProbe assays for its infectious disease programs to be combined with its fully automated PCR system, the Enigma ML. Financial terms of this agreement were not disclosed.

LabCorp Completes Acquisition of Monogram

LabCorp successfully completed the acquisition of Monogram Biosciences. As a result of the acquisition, Monogram became a wholly-owned subsidiary of LabCorp and Monogram shares ceased to be traded on the NASDAQ Global Market at the close of trading on August 4. “By adding Monogram’s innovative offerings to our extensive esoteric testing menu, we will advance our leadership in infectious disease and cancer testing, companion diagnostics, and personalized medicine,” stated David P. King, chairman and chief executive officer of LabCorp.

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