Resources for Food and Drug Administration (FDA)

FDA approval for Her2 image analysis

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Aperio Technologies 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. '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.

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