Dako, worldwide provider of cancer diagnostic solutions, 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 extensive 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 US 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 US 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.
According to the American Cancer Society, gastric or stomach cancer is the second leading cause of cancer-related death globally with over 1,000,000 new cases diagnosed each year. Early diagnosis is challenging because most patients do not show symptoms in the early stage, and in the United States, most patients are diagnosed in a later stage of gastric cancer. Approximately 22 per cent of stomach tumours are HER2-positive. This rate is the same in Europe and in Asia, where stomach cancer is particularly frequent.
HercepTest (Dako's pharmDx test) is an immunohistochemistry (IHC) assay used to identify patients with HER2-positive metastatic breast cancer eligible for treatment with Herceptin, and was launched in 1998.