TriPath Imaging Inc. and Ventana Medical Systems Inc. have announced that TriPath Imaging has received 510(k) clearance from the FDA for the Ventana Image Analysis System (VIAS) when used with tissues stained for p53. p53 is a tumor suppressor biomarker which is employed by pathologists as an adjunct to histopathology and is used to assist with diagnosis and the prognostic assessment of cancer.
Research studies have shown that high levels of the p53 protein have been associated with more aggressive breast cancers. Precise quantitative measurement of p53 expression in breast biopsy samples may be used to aid in the overall management and treatment of breast cancer patients.
"FDA clearance for the analysis of p53 increases the clinical utility of VIAS as an aid to the anatomical pathologist. This is the first time the p53 marker has been cleared by the FDA for use with an image analysis system," said Paul R. Sohmer, M.D., 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."


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