Image Analysis System Cleared for Use in Breast Biopsy

TriPath Imaging has received FDA clearance for the Ventana Image Analysis System (VIAS) when used with tissues stained for Ki-67. Ki-67 is a cell proliferation biomarker, which is employed by pathologists as an adjunct to histopathology and is used to assist with diagnosis and the prognostic assessment of cancer.

Precise quantitative measurement of Ki-67 expression in breast biopsy samples may be used to calculate the rate of cell proliferation by measuring the percentage of tumor cells that are actively dividing and, therefore, producing more cancer cells. Research studies have shown a significant correlation between high proliferation rates and shorter disease free and overall survival.