Diagnostics

U.S. FDA grants 510 clearance for image analysis system with HER-2/neu stain

Published in Cancer Weekly, September 13th, 2005

TriPath Imaging Inc. (TPTH) and Ventana Medical Systems, Inc., (VMSI) announced that TriPath Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for the Ventana Image Analysis System (VIAS) when used with tissues stained for HER-2/neu.

In May, 2005, the companies announced 510(k) clearance for VIAS when used with the Ventana estrogen (ER) and progesterone (PR) receptor assays.

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.

TriPath Imaging, Inc., headquartered in Burlington,...

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Source: Cancer Weekly (2005-09-13)

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