FDA CLEARS TRIPATH IMAGING'S VIAS APPLICATION

TriPath Imaging has received FDA 510(k) clearance to market Ventana Medical Systems' Ventana Image Analysis System (VIAS) when used with tissues stained for HER-2/neu.

HER-2/neu protein analysis aids in the management of breast cancer patients and is used by physicians to aid in prognosis and prediction of therapy outcomes for breast cancer.

"FDA clearance for the analysis of HER-2/neu clearly increases the utility of VIAS as an aid to the clinical assessment of breast cancer," said Paul Sohmer, chairman, president and CEO of TriPath Imaging. "We expect to continue to further expand the application menu supported by VIAS with additional 510(k) applications."