VISTA, Calif.--(BUSINESS WIRE)--Aperio Technologies, Inc. (Aperio), a global leader in digital pathology for the healthcare and life sciences industry, has received its second FDA clearance from the U.S. Food and Drug Administration (FDA) for reading digital PR (Progesterone Receptor) slides from a computer monitor using its patented ScanScope® digital slide scanning system. Aperio previously received FDA clearance for the reading of digital HER2 slides from a computer monitor in December 2007.
The ScanScope System is intended for use as an aid to the pathologist in the detection and quantitative measurement of PR (Progesterone Receptor) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for PR on a computer monitor. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
“Aperio’s FDA clearances for diagnosing digital HER2 and PR immunohistochemistry slides on a computer monitor demonstrate that our digital pathology system is equivalent to diagnosing glass IHC slides under a microscope,” stated Dirk Soenksen, CEO of Aperio. “Digital pathology is becoming an essential technology for improving the quality and efficiency of pathology services, and these FDA clearances will encourage wider adoption. Aperio is also pursuing FDA clearance for diagnosing digital H&E slides.”
Aperio is the first and only company to receive FDA clearances for diagnosing digital slides for clinical use in pathology. All of Aperio’s FDA clearances encompass the company’s complete digital pathology system, including its ScanScope slide scanners for creating digital slide images from glass microscope slides, and the SpectrumTM information management (pathology PACS) software for managing, viewing, and analyzing digital slides.
Aperio is the global technology and market share leader in digital pathology, with an installed base of more than 450 systems in 28 countries, including more than two-thirds of the top 15 rated U.S. hospitals, leading academic medical centers and reference laboratories, and more than 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. For clearance updates and more information please visit www.aperio.com.
Contact:
Aperio Vice President, Marketing Kevin Whiteley, 760-539-1177 kwhiteley@aperio.com or Myla Wagner Public Relations Myla Wagner, 925-736-7515 myla@mylawagnerpr.com
Source: Aperio Technologies, Inc.
