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www.fdanews.com/articles/90452-fda-clears-genetic-test-for-breast-cancer

FDA CLEARS GENETIC TEST FOR BREAST CANCER

February 6, 2007

The FDA has cleared the first genetic multivariate index assay, a diagnostic that reads multiple pieces of genetic information, to determine the probability that patients suffering from early-stage breast cancer will have a recurrence of the disease in five to 10 years.

The agency Feb. 6 cleared the MammaPrint test for marketing in the U.S. The test was developed by Agendia, based in the Netherlands, where the product has been on the market since 2005.

The tests will be processed through the firm's laboratory in the Netherlands, with an expected turnaround of less than one week to receive results, according to Steve Gutman, director of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety.