BioView's breast cancer scanner:
This article was originally published in Clinica
Executive Summary
The US FDA has given BioView 510(k) market clearance to expand the application of its automated scanning microscope and image analysis system, Duet, to use with breast cancer tissue specimens. The technology can be used to detect and quantify chromosome 17 and the HER-2/neu gene via fluorescence in situ hybridisation (FISH) in interphase nuclei from formalin-fixed, paraffin embedded specimens, probed by the PathVysion HER-2/neu DNA probe kit made by Vysis, a subsidiary of Abbott Laboratories. The test is an important factor in evaluating and selecting certain breast cancer patients for Herceptin therapy, said the Rehovot, Israel-based firm. Duet is already cleared for use with haematopoietic cells, amniotic cells and urine cells.