New IHC Kit Detects Folate Receptor Alpha Expression

Biocare Medical has 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 assay is the result of collaboration between Morphotek® Inc., (a subsidiary of Eisai Inc.,) and Biocare. 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. The FRalpha test is intended to determine which patient tumors express FRalpha, and this 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, Diagnostics 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.