New Breast Cancer Diagnostic Approved - FDA Debate Begins

A new gene-based microarray diagnostic for breast cancer, called MammaPrint (yes, that's really the name they chose), was just approved by the FDA. This test will compete along with Genomic Health's Oncotype DX. The FDA is now determining whether these types of diagnotics should be regulated like medical devices, including extended clinical trials. While it seems like they should have more oversight, such trials could add a decade or more for such predictive tests to hit the market.