Dako: New diagnostic tests provide hope for patients with stomach cancer

03-18-2010: Dako announced that two of its products have obtained a CE-mark as diagnostic tests for selecting patients with metastatic stomach (gastric) cancer who may benefit from Herceptin(TM) treatment. Dako's HercepTest(TM) and HER2 FISH pharmDx(TM) enable physicians to identify the unique group of cancer patients that might benefit from the drug. New research suggests that patients with metastatic stomach cancer live longer when treated with the drug.

Professor Giuseppe Viale, M.D., F.R.C. Path, Director of the Division of Pathology at the European Institute of Oncology, and Professor of Pathology at the University of Milan, declared: "This is an important advance for the treatment of a patient group with a very poor prognosis. Dako's new diagnostic test helps identify patients with metastatic HER2-positive stomach cancer - an aggressive form of cancer where the options for treatment have previously been limited. Now, with Dako's HercepTest(TM) and HER2 FISH pharmDx(TM), physicians in Europe have diagnostic tools that allow them to identify the patient group with metastatic stomach cancer that can benefit from a targeted treatment."

The CE-marking of Dako's HercepTest(TM) and HER2 FISH pharmDx(TM) in stomach cancer is based on the results of an international study. The study involved in the screening phase for assessing HER2 status more than 3700 patients at 135 sites in 24 countries including the following parts of the world: Asia, Australia, Europe, South and Central America and South Africa. The study showed that treatment with Herceptin(TM) in patients (N=584) with metastatic HER2-positive stomach cancer found by the use of Dako's diagnostic tests significantly prolongs the lives of patients with this aggressive cancer. Overall survival for patients with high levels of HER2 in the study was 16 months for patients treated with chemotherapy and Herceptin(TM) versus 11.8 months (on average) for patients receiving chemotherapy alone.