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The VS800 system is an automated digital slide creation, management, and viewing system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The VS800HER2 Manual Read (MR) of digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide of formalin-fixed, paraffin-embedded and neoplastic tissue IHC stained for HER2 receptors on a computer monitor. HER2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer. The VS800HER2 MR of digital slide application is intended for use as an accessory to the DakoHercepTest to aid the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide of formalin-fixed, paraffin-embedded and neoplastic tissue immunohistochemically stained for HER2 receptors on a computer monitor. When used with the Dako Hercep Test, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. Note: The actual correlation of the Dako Hercep Test to the Herceptin® clinical outcome has not been established.

The VS800 System is an automated digital slide creation, management and viewing system. The VS800 System components consist of an automated digital microscope slide scanner (VS800-SS) which include a computer, keyboard and mouse, operating monitor (VS800-MTR) and VS Viewer software (VS2-ASW-IDB). The system capabilities include digitizing microscope slides at high resolution, storing and managing the resulting digital slide images, retrieving and displaying digital slides, including support for remote access over wide-area networks, providing facilities for annotating digital slides and editing metadata associated with digital slides, and facilities for image analysis of digital slides. The remote digital slide viewing capabilities of the system support reading digital slides on a computer monitor, enabling Pathologists to make clinically relevant decisions analogous to those they make using a conventional microscope. Specifically, the system supports the pathologist in the detection of HER2/neu by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER2 receptors on a computer monitor. The VS800-SS (an automated digital microscope slide scanner) creates high resolution, color digital slide images of entire glass slides in a matter of minutes. High numeric aperture 20x objectives, specially designed for VS800-SS optical system and real time contrast auto focus system (AF) are used to produce high-quality images. VS800-SS employs a 2D CCD imager for fine image acquisition which is same technologies used in conventional microscope imaging system. VS800-SS captured image is as same as conventional microscope image. The VS-ASW-IDB (VS Viewer software) is a full-featured digital pathology information management system. The software runs on a server computer, which stores digital slide images on disk storage such as a RAID array, and which hosts an SQL database that contains digital slide metadata. The VS-ASW-IDB includes a web application and services which encapsulate database and digital slide image access for other computers. The VS-ASW-IDB also includes support for locally or remotely connected Image Server, which run digital slide viewing software provided as part of VS-ASW-IDB. The laboratory technician or operator of VS800-SS loads glass microscope slides into a specially designed slide carrier with a capacity up to 100 slides per carrier (300 total). The scanning process begins when the operator starts the VS800-SS scanner and finishes when the scanner has completed scanning of all loaded slides. As each glass slide is processed, the system automatically stores stitched images as a single digital slide image, which represents a histological reconstruction of the entire tissue section. When the slide scanning finished, then operator of scanner will confirms the image quality and records to the database. When the images are recorded, pathologists or authorized parsons can observe these images to access the VS-ASW-IDB.