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Dako Enters Collaboration with Genentech on Diagnostic Tests for Patients with Stomach Cancer

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Dako has signed an agreement with Genentech, Inc., a wholly-owned member of the Roche Group, to collaborate on the regulatory submissions of Dako’s HercepTest™ and HER2 FISH pharmDx™ as companion diagnostics for Herceptin (trastuzumab) in patients with advanced HER2-positive stomach (gastric) cancer.

The collaboration involves the use of Dako's experience in developing cancer diagnostic tests to identify cancer patients who may receive greater benefits from a certain therapy.

Under the terms of the agreement, Dako and Genentech will collaborate on regulatory submissions for HercepTest™ and HER2 FISH pharmDx™ in the U.S. market to identify patients with stomach cancer who may be eligible for treatment with Herceptin if Herceptin is approved for use against that disease.

Based on the Herceptin ToGA Phase III study results, which were presented on May 31, 2009 at the American Society for Clinical Oncology Annual Meeting in Orlando, Florida, Genentech may seek regulatory approvals in the U.S. for the use of Herceptin in advanced HER2-positive stomach cancer.

“Herceptin and Dako’s companion diagnostics HercepTest™ and HER2 FISH pharmDx™ have brought significant benefit to women with HER2-positive breast cancer. We are very excited to work with Genentech to extend these successful companion diagnostics to patients with stomach cancer,” says Lars Holmkvist, CEO and President of the Dako Group.

The collaboration is in line with Dako’s ongoing strategy to combine its strengths with biotechnology and pharmaceutical companies to develop the offering of Dako’s companion diagnostic assays.

“We are very pleased to announce our collaboration with Genentech to potentially further expand the market for targeted therapies. We see great potential in a strong collaborative approach between biotechnology and pharmaceutical companies, and diagnostic companies, in targeting the right drugs for the right patients, both to improve patient care and more efficiently manage health care costs,” says Lars Holmkvist.