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-New Assay, Developed in Collaboration with Morphotek, Uses Proprietary Technology-
Concord, CA and Exton, PA, March 20, 2012 – In partnership with Morphotek® Inc., a subsidiary of Eisai Inc., Biocare Medical announced the release of its in vitro diagnostic immunohistochemical (IHC) kit to detect folate receptor alpha (FRalpha) expression in formalin fixed paraffin embedded (FFPE) tissues at the U.S. College of Anatomical Pathology Conference in Vancouver, British Columbia earlier this week. The kit will be available in the U.S. as a Class I IHC IVD assay and is CE marked for use in Europe.
The introduction of this new assay, the result of a collaboration between Morphotek and Biocare, is intended to determine which patient tumors express FRalpha, which may support the development of new cancer treatments.
“The development of a highly characterized and high affinity folate receptor alpha antibody IHC kit is extremely important; not only for its potential use in the development of targeted therapeutics, and hopefully it could be developed into an independent prognostic marker for various cancers,” said Dr David Tacha, Chief Scientific Officer and VP of R&D, Biocare Medical.
“Having an IHC kit to detect folate receptor alpha will support our efforts to identify new treatments for a variety of cancers,” said Elizabeth Somers, Associate Director Diagnostic Development of Morphotek. “We are pleased to be part of the development of such an assay because having the ability to identify patient tumors that are positive for a target will enable us to learn more about the disease and the behavior of cancers that are expressing a given target.”
Morphotek, which has expertise in monoclonal antibody development, licensed its proprietary monoclonal antibody 26B3, which specifically detects human folate receptor alpha, to Biocare in March, 2011 for the development of this kit for use with Biocare’s intelliPATH™ Automated IHC Stainer or in a manual format.
Biocare has worldwide rights to manufacture and distribute the kit, which will detect folate receptor alpha on a variety of tumor tissues.
About Folate Receptor Alpha
Mouse anti-human folate receptor alpha monoclonal antibody 26B3 specifically recognizes the alpha isoform of folate receptor. FRalpha is a cell surface protein that is primarily expressed on the apical surface of some polarized epithelial cells of normal tissues (such as kidney, lung, breast, and salivary glands) and on several cancers of epithelial origin, including ovarian cancer, thyroid cancer, non-small cell lung adenocarcinoma (NSCL) and endometrial cancers.
About Biocare Medical
Biocare Medical LLC is an innovator in developing and supplying world class automated immunohistochemistry (IHC) instrumentation, and the full range of reagents for IHC lab testing. Biocare is the market leader in simultaneous Multiplex IHC and antibody development, which solves difficult clinical problems and accelerates turnaround time. The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets using tissue immunostaining and in situ hybridization methods. Biocare medical is headquartered and has manufacturing facilities in Concord, Calif., and has a global distribution network. For more information, please visit www.biocare.com.
Morphotek®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit www.morphotek.com
About Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s key areas of commercial focus are neurology and oncology. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.