U.S. FDA clears new genetic breast cancer test


U.S. regulators cleared a new genetic test on Monday that helps predict tumor recurrence and long-term survival in breast cancer patients with higher risk of the cancer returning.
The U.S. Food and Drug Administration approved the new test, which uses fluorescent probes to detect the activity of genes that may portend increased tumor activity.
The agency cited study data from 767 patients in Denmark that showed the test was effective in estimating the time of a tumor recurrence and overall survival.
Prediction of tumor recurrence and overall survival can be a tool for doctors to guide further treatment, the FDA said.
The test is made by privately-held Dako Denmark A/S. Late last year, Beckman Coulter Inc announced it would acquire certain technology from Dako to analyze cells in blood and other fluids, but Dako retained its cancer-focused diagnostics business.
Breast cancer is the most common cancer worldwide among women and the fifth most deadly, killing about 502,000 people a year, according to the World Health Organization.