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The Omnyx Manual Read of the Digital HER2 Application on the Omnyx IDP System is intended for in vitro diagnostic use as an aid to pathology professionals for creating, storing, annotating, measuring, and viewing digital Whole Slide Images (WSI) from formalin-fixed, paraffin-embedded (FFPE) tissue sections stained with the Dako HercepTest™. The Omnyx Manual Read of the Digital HER2 Application on the Omnyx IDP System is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in digital images of FFPE breast cancer tissue immunohistochemically stained with the Dako HercepTest™ and viewed on a computer monitor. The Dako HercepTest™ is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.

The Omnyx Manual Read of the Digital HER2 Application on the Omnyx IDP System is intended to aid pathology professionals in creating, storing, annotating, measuring, and viewing digital Whole Slide Images (WSI) from formalin-fixed, paraffin-embedded (FFPE) tissue sections stained with the Dako HercepTest™. The system is composed of the following components: - VL4 Scanner: A hardware device that captures and compresses bright field images of tissue samples. - Data and Workflow Infrastructure: A set of networked applications which enables case data entry, acquisition, indexing, storage and acceptance of digital images, workflow management, and retrieval of case and image data. - Histology Workstation: The application which permits the histologist to review or enter case data and check quality of scanned images. - Pathology Workstation: The application which allows the pathologist to retrieve case data and review and annotate slide images. Hardware: The Omnyx™ VL4 scanner is an automated imaging system that can be loaded with up to 4 slides at a time. The VL4 Scanner outputs its images and metadata to the Omnyx Digital Archive, which receives and stores the images and data. Software: The Omnyx software is composed of 1) the VL4 scanner software which performs tissue identification, scan planning, focusing, image acquisition, stitching and compression of digital slide images and sends them to the Digital Archive and 2) the DPS software that manages the Histologist and Pathologist workstation functions, image viewer, workflow service, database, interface engine, APLIS service, digital archive, image store and the administrator client application.