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Dako Obtains CE Mark For Two New Diagnostic Tests

Dako, a Denmark-based firm of tissue-based cancer diagnostics, said 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 a group of cancer patients that might benefit from the drug.

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 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.

Giuseppe Viale, professor and director of the division of pathology at the European Institute of Oncology and professor of pathology at the University of Milan, said: “This is an 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.

“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.”

Lars Holmkvist, CEO of Dako, said: “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 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.”