Aperio Receives Second FDA Clearance for Diagnosis of Digital Breast Cancer Slides
Aperio has recently received FDA clearance for interpretation of progesterone receptor to its already approved HER2 clearance for digital reads as well as image analysis applications for ER and PR.
Excellent news for signing out breast cancers with whole slide images on a computer monitor.
The recent press release states: "Aperio has received its second FDA clearance from the U.S. Food and Drug Administration (FDA) for reading digital PR (Progesterone Receptor) slides from a computer monitor using its patented ScanScope® digital slide scanning system. Aperio previously received FDA clearance for the reading of digital HER2 slides from a computer monitor in December 2007.
The ScanScope System is intended for use as an aid to the pathologist in the detection and quantitative measurement of PR (Progesterone Receptor) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for PR on a computer monitor. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer."
