Aperio receives FDA clearance for ScanScope
Aperio Technologies, a digital pathology services and systems provider, has received clearance from the FDA to market the manual read of digital HER2 slides from a computer monitor using its patented ScanScope digital slide scanning system. Aperio said it is the first company to receive FDA clearance for the manual read of digital slides for clinical use in pathology.
The Vista, Calif.-based company said 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 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 analyzing digital slides.
The Vista, Calif.-based company said 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 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 analyzing digital slides.