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Ventana receives FDA clearance for Estrogen Receptor (ER) Image Analysis and Digital Read Application for breast cancer
Date:12/5/2013

TUCSON, Ariz., Dec. 5, 2013 /PRNewswire/ -- Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Companion Algorithm ER (SP1)1 image analysis algorithm used with the VENTANA iScan Coreo scanner running Virtuoso2 software.  With this clearance, Ventana is now the only company in the industry offering a comprehensive portfolio of FDA-cleared image analysis algorithms and digital read applications for the five key immunohistochemistry (IHC) breast markers.  

(Photo:  http://photos.prnewswire.com/prnh/20131205/LA28038)

There are two intended uses obtained with the 510(k) clearance for ER:  first, clinical use of the software algorithm to semi-quantify the ER biomarker, and second, digital read, or clearance to manually read and score the ER biomarker using a computer monitor, in lieu of a microscope. This means the pathologist will be able to digitally view a slide on a computer monitor, assign a score, and then sign out the case with a diagnosis or opinion, with or without the assistance of an image analysis algorithm. 

All IHC breast markers in the Ventana portfolio have both image analysis and digital read application FDA 510(k) clearances. Along with the Companion Algorithm ER (SP1) image analysis software, the full breast panel includes HER2 (4B5), PR (1E2), Ki-67 (30-9) and p53 (DO-7) image analysis algorithms along with their accompanying VENTANA IHC assays3.

"The biomarkers, scanner, and image analysis software have been optimized and clinically validated to work together as a system.  Not only does this provide a po
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SOURCE Ventana Medical Systems, Inc.
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