Aperio Receives FDA Clearance for ER and PR Image Analysis Application

Big news today from Aperio:

Aperio has received clearance from the U.S. Food and Drug Administration (FDA) to market the ER and PR image analysis applications available through its patented ScanScope® slide scanning system.  The FDA-cleared immunohistochemistry (IHC) image analysis applications are intended to be used as an aid to pathologists in detecting and quantifying ER (estrogen receptor) and PR (progesterone receptor) 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 SpectrumTM 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.

I try not to parrot Aperio press releases too often on this blog, but this really is important; it means that, together with Aperio's previously-cleared Her2 analysis application, we can now offer customers a complete FDA-cleared solution for breast cancer panels.