Applied Imaging Corp. has received 510(k) clearance from the US FDA to market its Ariol Her-2/neu FISH application, which is designed to detect Her-2/neu gene amplification in breast cancer biopsy samples via fluorescence in situ hybridization (FISH).
The application complements and completes the breast cancer panel on the Ariol system which now includes 510(k) cleared assays for Her-2/neu Immunohistochemistry (IHC), Her-2/neu FISH, Estrogen Receptor, and Progesterone Receptor. The Ariol Her-2/neu FISH application assists in the analysis of a complex test that is an important factor in the evaluation and selection of certain breast cancer patients for Genentech's Herceptin (Trastuzumab) therapy. Herceptin is the first humanized antibody approved for the treatment of Her-2 positive metastatic breast cancer. Herceptin targets and blocks the overexpression of Her-2 protein. Research indicates that women with Her-2 positive metastatic breast cancer have a more aggressive disease, greater likelihood of recurrence, poorer prognosis and approximately half the life expectancy of women with Her-2 negative breast cancer, a company release stated.
"This FDA clearance is consistent with our plan to enhance the menu and add value to our Ariol pathology workstation for both clinical and research applications", said Robin Stracey, president and CEO of Applied Imaging Corp.
The Ariol Her-2/neu FISH application uses the PathVysion Her-2/neu DNA Probe kit from Vysis, Inc., Downers Gove, IL.
Ariol is an automated scanning microscope and image analysis system which is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and quantification of cells of interest based on particular colour, intensity, size, pattern, and shape. A number of research applications are also available on Ariol including Angiogenesis, DNA Ploidy and Tissue Microarray.