• Fda Approval Received for Her2 Image Analysis Application

Laboratory Products

Fda Approval Received for Her2 Image Analysis Application

Apr 24 2008

Aperio Technologies, Inc has received clearance from the US Food and Drug Administration (FDA) to market the HER2 image analysis application available through its patented ScanScope® slide scanning system. The FDA-cleared immunohistochemistry (IHC) image analysis application is
intended to be used as an aid to pathologists in detecting and quantifying HER2 protein expression from digital slide images created by Aperio’s slide scanning systems.
Aperio’s FDA clearance encompasses the company’s complete digital pathology system, including ScanScope® scanners for creating digital slide images from microscope slides, the Spectrum™ digital pathology information management system for managing, viewing, and analysing
digital slides, and the specific image analysis application which performs the automated scoring of IHC HER2 breast cancer digital slides.

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