SOURCE: Dako Denmark A/S

January 15, 2008 04:25 ET

Dako receives FDA approval of a genetic test for patients with breast cancer

GLOSTRUP, DENMARK--(Marketwire - January 15, 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 EC-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

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