Breast cancer therapy management diagnostic
This article was originally published in The Gray Sheet
Executive Summary
Receipt of 510(k) allows ChromaVision Medical Systems to market Acis digital microscope system as complement to DakoCytomation's HercepTest, which measures Her-2/neu levels to guide Herceptin chemotherapy. Already 510(k)-cleared to detect estrogen and progesterone levels, Acis uses color-based imaging to detect, count and classify the presence of the Her-2 protein...