American Association for Clinical Chemistry
Better health through laboratory medicine
April 2010 Clinical Laboratory News: Industry Profiles

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April 2010: Volume 36, Number 4

Abbott, GlaxoSmithKline to Develop Test for Skin Cancer Drug

Abbott and GlaxoSmithKline announced that they will jointly develop and commercialize a molecular diagnostic test to aid in selecting patients who may benefit from a skin cancer treatment being developed by GlaxoSmithKline. The companies plan to develop a PCR test for use on Abbott’s m2000 automated molecular instrument system that will detect MAGE-A3, a tumor-specific antigen expressed in skin and other cancers, but not normal cells.

GlaxoSmithKline’s MAGE-A3 antigen-specific cancer immunotherapeutic is being evaluated as an adjuvant treatment for melanoma in a Phase III clinical study. Patients must have MAGE-A3 expressing melanoma tumors to be eligible for the treatment. Previously, the companies announced a similar arrangement involving the MAGE-A3 marker in non-small-cell lung cancer. “This is an exciting continuation of our important collaboration,” said Stafford O’Kelly, head of Abbott’s molecular diagnostics business. “The agreement is indicative of our commitment to personalized medicine and our focus on developing innovative companion diagnostic tests that can be used to identify patients most likely to benefit from specific cancer therapies.”

US Oncology, Baylor Health to Launch Lab Joint Venture

US Oncology and Baylor Health Care System have formed a joint venture to operate a molecular diagnostics lab with a particular emphasis on validating the clinical utility of pharmacogenetic and companion diagnostic tests. The joint venture has leased a 172,000 square feet facility in Lewisville, Texas, and plans to employ more than 200 people by the end of this year, and more than 900 by 2014. Other investors in the $25 million collaboration include Pathologists Biomedical Laboratories and Texas Oncology. For now the venture is being called NewCo, pending the outcome of a branding campaign to select the final name.

GenomicVision Receives Grant to Develop FSHD Test

Genomic Vision, a biotechnology company in Paris focused on nanotechnology-based DNA analysis, has signed an agreement with and received a €250,000 grant from the Association Française contre les Myopathies to optimize and validate a diagnostic test for facio-scapulo-humeral dystrophy (FSHD), the third most prevalent form of muscular dystrophy. The test uses Genomic Vision’s molecular combing technology, which enables individual sections of single DNA molecules to be visualized directly. Genomic Vision has been working to develop the test with the Université de la Méditerranée and the Timone Hospital in Marseille.

License Agreement Signed for Antibodies to Group 1 Influenza

Boston-based Dana-Farber Cancer Institute and Sanford-Burnham Medical Research Institute in LaJolla, Calif. have signed a license agreement with Roche and its wholly owned subsidiary, Genentech, that grants the companies exclusive rights to manufacture, develop, and market human monoclonal antibodies to treat and protect against group 1 influenza viruses, which include the current seasonal and H1N1 strains. Researchers at Dana-Farber, Sanford-Burnham, and CDC first reported discovery of the antibodies in February 2009. The antibodies attach to the stem region of viral proteins rather than the head region—the target of current influenza vaccines—and appear to prevent changes in the protein that are necessary for viral entry into the host cell. Terms of the agreement were not disclosed, but Dana-Farber and Sanford-Burnham will receive license fees and may receive milestone payments and royalties if treatments or diagnostics result from the antibodies.