Agendia Gets FDA Approval For Breast Cancer Test
Centient Biotech Investor submits: A privately held Dutch biotech, Agendia BV (see Agendia BV Closes Second Round), scored a big win today when it got approval from the FDA for its breast cancer recurrence test, MammaPrint®. MammaPrint® analyzes gene expression profiles of 70 known cancer genes in a cancer sample to predict whether a woman is at risk for recurrence from breast cancer. The company also has a test to determine the tissue type of a tumor of unknown origin. That test is called CupPrint®. Women at high risk have about twice the recurrence rate as women in the low risk category. The test predicts who is in the low risk category with at least 90% accuracy. For those in the high risk category, only 23% actually got a recurrence within five years, so it is possible the test overestimates this group.
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