Aperio Receives FDA Approval for HER2 Image Analysis Application

Press release from Aperio:

Aperio Technologies, Inc., (Aperio), a global leader in digital pathology for the healthcare and life sciences industry, has received clearance from the U.S. Food and Drug Administration (FDA) to market the HER2 image analysis application available through its patented ScanScope® slide scanning system. The FDA-cleared immunohistochemistry (IHC) image analysis application is intended to be used as an aid to pathologists in detecting and quantifying HER2 protein expression from digital slide images created by Aperio’s slide scanning systems.

"FDA approval for the HER2 image analysis application provides clinical customers with access to powerful quantitative image analysis algorithms for breast cancer pathology, while allowing them to benefit from the most advanced digital pathology system available today," stated Dirk Soenksen, CEO and founder of Aperio. "Now that we have established the infrastructure of complying with the FDA’s Quality System Regulation (QSR), we are poised to accelerate our efforts to increase the clinical utility of digital pathology."

Aperio’s FDA clearance encompasses the company’s complete digital pathology system, including ScanScope® scanners for creating digital slide images from microscope slides, the Spectrum(TM) digital pathology information management system for managing, viewing, and analyzing digital slides, and the specific image analysis application which performs the automated scoring of IHC HER2 breast cancer digital slides.

Aperio is the technology and market share leader in digital pathology, with an installed base of more than 300 systems in 25 countries, including more than two-thirds of the top 15 rated U.S. hospitals, leading academic medical centers and reference laboratories, and two-thirds of the top 15 pharmaceutical companies. During 2007, Aperio continued to advance the utility of digital pathology with pivotal technology, including the introduction of a 100x rapid oil-immersion slide scanner, creation of the world’s first terapixel digital slide image, development of TMA Lab II, a state-of-the-art digital pathology solution for tissue microarray analysis, and receipt of a patent for image pattern recognition technology based on vector quantization.

Aperio is digitizing pathology. We provide systems and services for digital pathology, which is an environment for the management and interpretation of pathology information that originates with the digitization of a glass slide. Aperio’s award-winning ScanScope® slide scanning systems and Spectrum(TM) digital pathology information management software improve the efficiency and quality of pathology services for pathologists and other professionals. Applications include education, remote viewing, archival and retrieval, basic research, and image analysis. Aperio’s products have been cleared by the FDA for clinical use in HER2 image analysis, and are intended for research and education use for other applications. For more information, please visit www.aperio.com

First FDA Clearance for Total Digital Pathology System Comprising Slide Scanner, Data Management Software, and Algorithms