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Biotech Business Week

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Breast Cancer



U.S. FDA grants clearance for ER and PR image analysis system for breast cancer



June 6th, 2005

TriPath Imaging, Inc. (TPTH), and Ventana Medical Systems, Inc. (VMSI), announced TriPath Imaging has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Ventana Image Analysis System (VIAS) when used with tissues stained for estrogen receptor (ER) and progesterone eeceptor (PR).

As previously announced, Ventana has entered into an agreement to market globally the Ventana-branded interactive histology image analysis system from TriPath Imaging.

"This is clearly a gating event that sets the table for a Ventana launch of VIAS," said Paul R. Sohmer, MD, chairman, president, and CEO of TriPath Imaging. "The analysis of ER...


Source: Biotech Business Week (2005-06-06)

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