Manual Read of HER2 Digital Slides Approved
The ScanScope digital slide scanning system, designed by Aperio Technologies, Incorporated, has been approved by the Food and Drug Administration. The system is intended for use with the company’s Dako HercepTest, as described by the company in their press release about the approval.
The tool is intended to help clinicians determine if patients are candidates for Herceptin therapy. The ScanScope assists in the detection and semi-quantification of HER2 protein expression.
The FDA approval includes the entire digital pathology system. Included in that are ScanScope scanners to create slide images from microscopes and the company’s SpectrumTM digital pathology information management for viewing, analyzing, and managing slides.
Clinicians can read slides procured from patients on the computer monitor, streamlining breast cancer pathologic analysis. That is enabled by the ScanScope system, which produces high-quality, seamless digital images of whole slides. The system also incorporates JPEG2000 compression utilities.
This approval is the first granted by the FDA for manual read of digital slides in the clinical pathology setting. Aperio is the leading national provider of digital technology solutions.
January 22, 2008 Related topics: Laboratory, Product Approval & Certification, New Technology & Innovation, Laboratory Equipment