Aperio Receives FDA Clearance for ER and PR Image Analysis Applications.Digital Pathology pathology, study of the cause of disease and the modifications in cellular function and changes in cellular structure produced in any cell, organ, or part of the body by disease. Leader Adds Third FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Clearance for Digital Pathology in Breast Cancer VISTA, Calif. -- 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[R] slide scanning system. The FDA-cleared immunohistochemistry (IHC IHC Immunohistochemistry IHC Intermountain Health Care IHC Inner Hair Cells IHC International Harvester Company IHC Internet Healthcare Coalition IHC Indian Head Cent IHC Interactive Health Communication IHC International Hurricane Center ) image analysis applications are intended to be used as an aid to pathologists in detecting and quantifying ER (estrogen receptor estrogen receptor A protein of a superfamily of nuclear receptors for small hydrophilic ligands–eg, steroid hormones, thyroid hormone, vitamin D, retinoids; the presence of ERs in breast CA generally is associated with a better prognosis, as they respond to ) and PR (progesterone receptor progesterone receptor A progesterone-binding protein complex found in the cytoplasm of certain cells in particular of the breast, which belongs to the nuclear receptor family. See Progesterone receptor assay. Cf Estrogen 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 Spectrum(TM) digital pathology information management system for managing, viewing, and analyzing digital slides, and the specific image analysis applications which perform the automated au·to·mate v. au·to·mat·ed, au·to·mat·ing, au·to·mates v.tr. 1. To convert to automatic operation: automate a factory. 2. 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 "Digitizer" redirects here. For the computer device, see Digitizing tablet. For the digitizer in Tablet PC's, see Tablet PC. Digitizing or digitization 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 dig·i·tize tr.v. dig·i·tized, dig·i·tiz·ing, dig·i·tiz·es To put (data, for example) into digital form. dig of a glass slide. Aperio's award-winning ScanScope[R] 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 are FDA cleared for specific clinical applications, and are intended for research and education use for other applications. For more information, please visit www.aperio.com. |
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