Aperio Technologies wins clearance from US Food and Drug Administration (FDA) to market the manual read of digital HER2 slides from a computer monitor using its ScanScope digital slide scanning system
The FDA-cleared system is intended for use as an accessory to the Dako HercepTest to aid pathologists in the detection and semi-quantitative measurement of HER2 protein expression to assess breast cancer patients for whom herceptin treatment is being considered.
"The FDA clearance for the manual read of digital HER2 slides from a computer monitor is an important milestone for Aperio, as well as for breast cancer pathology," stated Dirk Soenksen, CEO and founder of Aperio.
"This clearance was made possible by the high quality seamless digital whole-slide images that are produced using our ScanScope systems, including the use of Jpeg2000 compression.
"We are excited to provide pathologists with digital pathology tools to increase the quality and efficiency of pathology services".
Aperio is the first company to receive FDA clearance for the manual read of digital slides for clinical use in pathology.
The FDA clearance encompasses the company's complete digital pathology system, including ScanScope scanners for creating digital slide images from microscope slides, and the Spectrum digital pathology information management system for managing, viewing, and analysing digital slides.
