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TriPath's Ki-67 with Ventana imager:

This article was originally published in Clinica

Executive Summary

TriPath Imaging has received US FDA 510(k) market clearance to use a Ventana-branded version of its interactive histology image analysis system with tissues stained for Ki-67, a cell proliferation biomarker for helping with the diagnosis and prognostic assessment of cancer. "This is the first time the Ki-67 marker has been cleared by the FDA for use with an image analysis system," said Paul Sohmer, TriPath's chairman, president and CEO. The Ventana image analysis system received US clearance last year for use with oestrogen receptor, progesterone receptor and HER-2/neu assays. In 2004, TriPath, of Burlington, North Carolina, gave Tucson, Arizona-based Ventana exclusive rights to sell and distribute worldwide a Ventana-branded version of its imaging system, optimised for both Ventana and TriPath assays.

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