Aperio nets FDA clearance for IHC image analysis apps

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Aperio Technologies has received clearance from the FDA to market immunohistochemistry (IHC) image analysis applications available through its ScanScope slide scanning system. 

The FDA-cleared image analysis applications are intended to be used as an aid to pathologists in detecting and quantifying estrogen receptor and progesterone receptor protein expressions from digital slide images created by slide scanning systems, according to the Vista, Calif.-based Aperio.

The clearance encompasses the 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 image analysis applications that perform the automated scoring of ER and PR breast cancer digital slides, the company said.