New Genetic Breast Cancer Approved for Market

Dako Denmark A/S announced that the FDA cleared their new test to evaluate breast cancer patients for likelihood of disease recurrence, the Top2A FISH pharmDx tests for the presence of the Top2A gene, as described in a press release issued by Dako Denmark.

The new test utilizes fluorescence in situ hybridization (FISH) to evaluate specimens procured by the patients. Testing is completed with a small sample of the breast specimen.

The Top2A FISH pharmDx test is indicated for use in patients who are premenopausal or have characteristics that indicate a more virulent tumor, such as larger tumors or increased involvement of lymph nodes.

The test is indicated as an adjunct prognostic tool in patients with breast cancer, particularly in combination with HER2-neu assessment. When results are combined with other data, clinicians can more accurately predict disease course.

Topoisomerase 2 alpha (Top2A) is a gene that participates in the replication of DNA. This is the first test approved to evaluate this gene in malignancy. Changes in Top2A expression indicates that patients are either more likely to have a tumor recurrence or that long-term survival is decreased.

Data was collected by Dako Denmark in a series of Danish women with breast cancer who underwent definitive surgery followed by chemotherapy. The study was a multi-center trial, with more than 20 different participating facilities. Over 750 women with high risk tumors were assessed. Study findings indicated that the test was predictive of disease course and provided clinicians with beneficial information to guide treatment planning.

Agendia’s prognostic tool, MammaPrint, has been approved for more than a year, as detailed on Hospital Buyer. The company plans to seek additional indications for the test, which is generally intended for older women with breast cancer.

January 25, 2008 Related topics: Product Approval & Certification, Radiation Oncology, Laboratory Equipment, Diagnostic, Surgery, Hematology & Oncology

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