The FDA-cleared immunohistochemistry (IHC) image analysis applications are intended to be used as an aid to pathologists in detecting and quantifying estrogen receptor (ER) and progesterone receptor (PR) protein expressions 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 analyzing digital slides, and the specific image analysis applications which perform the automated scoring of ER and PR breast cancer digital slides.
Dirk Soenksen, CEO of Aperio, said: “Aimed with these clearances, our customers can now take full advantage of our new digital IHC software to optimize their workflow and streamline reporting, while enjoying the benefits of quantitative image analysis.”