Dako A/S: FDA Approval of Diagnostic Tests Provides Hope for Patients with Stomach Cancer

GLOSTRUP, DENMARK--(Marketwire - October 21, 2010) - Dako has received approval from the U.S. Food and Drug Administration (FDA) to expand the intended use for HercepTest™ and HER2 FISH pharmDx™ Kit to include patients with metastatic gastric or gastroesophageal junction adenocarcinoma (stomach cancer). Dako's diagnostic tests are indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered. The FDA has simultaneously approved the use of Herceptin® in combination with chemotherapy for HER2-positive, metastatic stomach cancer or cancer of the gastroesophageal junction. Results from a recent clinical study indicate that patients with HER2-positive metastatic stomach cancer live longer when treated with Herceptin® in combination with chemotherapy, compared to chemotherapy alone.

Sunil S. Badve, MB, BS, FRCPath, professor at the Indiana University, Department of Pathology & Laboratory Medicine (USA) and diplomat of the American Board of Pathology in Anatomic and Clinical Pathology, states:

"Dako's HercepTest™ and HER2 FISH pharmDx™ Kit will be a great advance to the identification of patients with metastatic stomach cancer who are appropriate for HER2 targeted therapy with Herceptin®. The diagnostic tests can identify the group of patients having HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma, and are appropriate candidates for receiving the right combination of targeted treatment and chemotherapy. With these diagnostic kits we now have tools to aid in the selection of a therapy for approx. 22% of the estimated 21,130 Americans who are diagnosed with stomach cancer each year."

The FDA approval of Dako's HercepTest™ and HER2 FISH pharmDx™ Kit for use in stomach cancer patients in the United States is based on the positive results of an international Phase III study (ToGA).In the screening phase for assessing HER2-status, the study involved more than 3,700 patients at 122 sites in 24 countries. The FDA-approved dataset (N=594) showed that treatment with Herceptin® in combination with chemotherapy in patients 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.

"The FDA approval underlines our commitment to develop high quality diagnostic tests to identify the right cancer patients for specific cancer therapy. We have seen how Dako's HercepTest™ and HER2 FISH pharmDx™ Kit combined with Herceptin® treatment have revolutionized the field of breast cancer. It is our hope that these diagnostic kits will help patients with HER2-positive stomach cancer just as much," 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. An estimated 21,130 Americans were diagnosed with stomach cancer and more than 10,600 Americans died from the disease in 2009, according to the American Cancer Society (ACS). More than 64,000 Americans are currently living with the disease. 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.

HercepTest™ and HER2 FISH pharmDx™ Kit carry the CE mark in the European Union.

About HercepTest™ and HER2 FISH pharmDx™ Kit
HercepTest™ is an immunohistochemistry (IHC) assay used to identify the patients with HER2-positive metastatic breast cancer who are eligible for treatment with Herceptin®; HercepTest™ was launched in 1998. The joint approval of Herceptin® and HercepTest™ was the first example in history of a diagnostic biomarker linked to a specific therapy. This indication has been expanded in the U.S.A to include patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest® is a registered trademark of Genentech, Inc.

HER2 FISH pharmDx™ Kit, a direct fluorescence in situ hybridization (FISH) assay, was designed to quantitatively determine HER2 gene amplification in breast cancer specimens as an aid in the assessment of patients for whom Herceptin® treatment is being considered. This indication has been expanded now to include metastatic gastric or gastroesophageal junction adenocarcinoma.

About Dako
Dako, located in Denmark, is a global leader in tissue-based cancer diagnostics. Hospitals 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 80 countries, Dako covers essentially all of the global anatomic pathology markets. Dako is owned by the private equity fund, EQT. www.dako.com