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Dako receives FDA approval of TOP2A FISH pharmDx™
15th January 2008

The US Food and Drug Administration has given Dako PMA approval to market its TOP2A FISH pharmDx™ assay. The assay is intended as an adjunct in determining the prognosis for high-risk breast-cancer patients.
Dako, a world-leading provider of cancer-diagnostic solutions, is the first company to receive FDA approval for a TOP2A diagnostic test for breast-cancer patients.
The test, TOP2A FISH pharmDx™, is marketed to assess clinical breast-cancer tissue specimens for changes in the status of the TOP2A. This information aids physicians in evaluating the prognosis for breast-cancer patients, since patients with normal TOP2A status have a better outcome than patients with TOP2A gene amplifications or deletions. TOP2A FISH pharmDx™ provides new prognostic information for additional groups of patients and may serve as an adjunct to existing HER2-testing.
“We are very pleased to announce the FDA approval of our TOP2A FISH pharmDx™ test. The TOP2A FISH pharmDx™ kit adds a new dimension to the way breast cancer will be treated in the future, giving oncologists and pathologists a reliable tool when assessing the disease prognosis for individual patients,” says Patrik Dahlén, CEO and President of Dako.
TOP2A FISH pharmDx™ is part of Dako’s range of pharmacodiagnostic products, and is based on the fluorescence in-situ hybridization (FISH) technique. TOP2A FISH pharmDx™ also has the CE-label within the European Union.
About TOP2A
TOP2A is a molecular target for the pharmacological action of anthracyclines. Anthracycline-based chemotherapy with doxorubicin or epirubicin is one of the most active regimens in breast-cancer treatment. However, these compounds have serious acute and long-term side effects, such as cardiotoxicity and leukemia. The predictive implications of TOP2A amplifications for optimal use of anthracycline therapy have been established for many European patients. It is an area of active research with promising initial results that require confirmation and extension in the context of currently available chemotherapeutic options. Whether TOP2A amplification is an independent predictive marker of response to any type of treatment (chemotherapy or immune-based) has yet to be determined in the United States.
Media contact:
Dako A/S
Anne Thommesen, Corporate Communications, +45 40 63 95 93
You can subscribe to news from Dako online at www.dako.com/news.
Dako, based in Denmark, 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 people 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