GLOSTRUP, DENMARK--(Marketwire - March 16, 2010) - Dako announced today 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™ treatment. Dako's HercepTest™ and HER2 FISH pharmDx™ 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™ and HER2 FISH pharmDx™, 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™ and HER2 FISH pharmDx™ 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™ 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™ versus 11.8 months (on average) for patients receiving chemotherapy alone.
"We have seen how Herceptin™ and Dako's HercepTest™ and HER2 FISH pharmDx™ have brought significant improvement to women with HER2-positive breast cancer. We believe this will help patients with HER2-positive stomach cancer as much as it has helped so many women with breast cancer. We are very pleased about this CE-marking as it underlines our goal to fight cancer. Improving the quality of stains and creating more accurate cancer diagnosis will ultimately result in better patient care," says Lars Holmkvist, CEO of Dako.
Stomach cancer is the second most common cause of cancer-related deaths 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. Approximately one in five of all stomach tumors are HER2-positive.
About HercepTest™ and HER2 FISH pharmDx™
HercepTest™ 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. The joint approval of Herceptin™ and HercepTest™ was the first example in history of a drug linked to a companion diagnostic.
HER2 FISH pharmDx™ kit is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification and is indicated as an aid in the assessment of patients for whom Herceptin™ treatment is being considered.
Dako is based in Denmark and is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako's know-how, reagents, instruments and software to make precise diagnoses and determine the most effective treatment for patients suffering from cancer. Employing more than 1000 persons and operating in more than 70 countries, Dako covers essentially all of the global anatomic pathology markets. Dako is owned by a private equity fund, EQT. www.dako.com