BioStratum Incorporated and DakoCytomation A/S have signed an agreement according to which DakoCytomation is granted a license to develop and commercialize diagnostic applications of the monoclonal antibody, MetaStain, which has demonstrated the potential to identify invasive epithelial cancers. The license covers U.S. and foreign patents and patent applications as well as the hybridoma which produces the antibody. Terms of the license agreement were not disclosed.

While studying the basal lamina, BioStratum's collaborating researchers at the Karolinska Institute in Stockholm, Sweden discovered that laminin-5 is involved in the migration of most epithelial cells as well as epithelial cell derived cancers. The degree to which a tissue biopsy stains with MetaStain, a monoclonal antibody that binds to the gamma-2 chain of laminin-5, was shown to predict a cancer's invasive potential (aggressiveness) and/or metastatic potential. The antibody will be marketed for use in research during the first half of 2003 and later be developed as a diagnostic test that, it is hoped, will allow physicians to better differentiate benign tumors from invasive cancers.

"We consider this license agreement a further validation of our research on the basal lamina," stated Dr. Claus Kuhl, Chief Executive Officer and Vice Chairman of BioStratum. "DakoCytomation is the world leader in immunohistochemistry-based diagnostics and ideally positioned to maximize the value of MetaStain to both researchers and physicians."

Antibodies to the gamma-2 chain of laminin-5 have also demonstrated the ability to prevent the growth and spread of highly invasive cancers both in vitro and in vivo. BioStratum is currently studying these antibody therapeutics in preclinical cancer models.