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Aperio Receives FDA Approval for HER2 Image Analysis Application

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Aperio Technologies, Inc. has received clearance from the U.S. 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.

“FDA approval for the HER2 image analysis application provides clinical customers with access to powerful quantitative image analysis algorithms for breast cancer pathology, while allowing them to benefit from the most advanced digital pathology system available today,” stated Dirk Soenksen, CEO and founder of Aperio.

“Now that we have established the infrastructure of complying with the FDA’s Quality System Regulation (QSR), we are poised to accelerate our efforts to increase the clinical utility of digital pathology.”

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 analyzing digital slides, and the specific image analysis application which performs the automated scoring of IHC HER2 breast cancer digital slides.