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Morphotek, Fujirebio to Develop CA125 II Assay as CDx

NEW YORK (GenomeWeb) – Eisai subsidiary Morphotek today announced a collaboration and licensing agreement with Fujirebio Diagnostics to validate and commercialize the CA125 II assay as a companion diagnostic to identify best responders to Morphotek's investigational ovarian cancer treatment.

The deal is for the use of the CA125 II assay on Fujirebio's Lumipulse Instrument System. The assay will be used to help select patients who may best respond to farletuzumab, Morphotek's investigational, humanized, monoclonal antibody, which binds to folate receptor alpha. While the protein is absent from normal tissue, it is highly expressed in ovarian cancer and some other epithelial tumors, Morphotek said.

Farletuzumab has been evaluated in a randomized, placebo-controlled Phase III trial in combination with carboplatin plus taxane in patients with relapsed platinum-sensitive ovarian cancer. Morphoteck said that prespecified subset analyses demonstrated that farletuzumab-treated patients with low CA125 levels correlated with longer progression-free survival and overall survival than patients who were treated with placebo.

As a result of the deal announced today, Fujirebio will have a worldwide license to develop, manufacture, and commercialize the CA125 II assay as a companion diagnostic.

Financial and other terms of the agreement were not disclosed.