Healthcare Industry News:  HER2 

Diagnostics FDA

 News Release - January 16, 2008

Aperio Receives FDA Clearance for Manual Read of HER2 Digital Slides

First Market Clearance for Manual Read of a Digital Slide

VISTA, Calif.--(HSMN NewsFeed)--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 manual read of digital HER2 slides from a computer monitor using its patented 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 SpectrumTM digital pathology information management system for managing, viewing, and analyzing digital slides.

Aperio is the technology and market share leader in digital pathology, with an installed base of more than 350 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. Aperio continues 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 a state-of-the-art solution for tissue microarray analysis, and development of unique image pattern recognition technology based on vector quantization.

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. For more information, please visit

Source: Aperio Technologies

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