Aperio nets second FDA clearance for digital breast cancer slides
Aperio Technologies has received its second FDA clearance for reading digital progesterone receptor (PR) slides from a computer monitor using its ScanScope digital slide scanning system.
The ScanScope System is intended for use as an aid to the pathologist in the detection and quantitative measurement of PR 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, according to the Ronkonkoma, N.Y.-based Aperio.
“Digital pathology is becoming an essential technology for improving the quality and efficiency of pathology services, and these FDA clearances will encourage wider adoption,” stated Dirk Soenksen, CEO of Aperio.
The ScanScope System is intended for use as an aid to the pathologist in the detection and quantitative measurement of PR 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, according to the Ronkonkoma, N.Y.-based Aperio.
“Digital pathology is becoming an essential technology for improving the quality and efficiency of pathology services, and these FDA clearances will encourage wider adoption,” stated Dirk Soenksen, CEO of Aperio.