Digital Pathology Leader Adds Third FDA Clearance For Digital Pathology In Breast Cancer

Main Category: MRI / PET / Ultrasound
Also Included In: Radiology / Nuclear Medicine;  Medical Devices / Diagnostics;  Breast Cancer
Article Date: 29 Aug 2008 - 3:00 PDT

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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 ER and PR image analysis applications available through its patented ScanScope® slide scanning system. The FDA-cleared immunohistochemistry (IHC) image analysis applications are intended to be used as an aid to pathologists in detecting and quantifying ER (estrogen receptor) and PR (progesterone receptor) protein expressions from digital slide images created by Aperio's slide scanning systems.

Aperio's FDA clearance encompasses the company's complete digital pathology system, including ScanScope scanners for creating digital slide images from microscope slides, the SpectrumTM digital pathology information management system for managing, viewing, and analyzing digital slides, and the specific image analysis applications which perform the automated scoring of ER and PR breast cancer digital slides.

"The addition of FDA cleared ER/PR image analysis applications to our previously cleared applications for HER2 underscores our commitment to provide clinicians and breast cancer patients with the most comprehensive entire-slide quantitative image analysis panel available anywhere," stated Dirk Soenksen, CEO of Aperio. "Aimed with these clearances, our customers can now take full advantage of our new digital IHC software to optimize their workflow and streamline reporting, while enjoying the benefits of quantitative image analysis."

In 2007, Aperio achieved more than 125% sales growth through continued adoption of its digital pathology platform across a wide spectrum of clinical, research and educational applications. Aperio has an installed base of more than 400 systems in 27 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.

About Aperio

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™ 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 are FDA cleared for specific clinical applications, and are intended for research and education use for other applications.

http://www.aperio.com