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Ariol™ is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol application is an accessory to the PathVysion® HER-2/neu DNA Probe kit (PathVysion, Vysis, Inc., Downers Grove, IL). PathVysion is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffinembedded human breast cancer tissue specimens. Results from the PathVysion kit are intended for use as an adjunct to existing clinical and pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy. The PathVysion kit is also indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the PathVysion kit provides the probes that offer direct visualization and manual enumeration of the HER2 and Chromosome 17 genes with a fluorescent microscope, the Ariol may be used as an accessory that provides automated enumeration.

Ariol™ is an automated scanning microscope and image analysis system.

The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. Cyto Vision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy. This particular CytoVision software application is an accessory to the CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer's Grove, IL) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.

The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. Cyto Vision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy.

Ariol™ is an automated scanning microscope and image analysis system. It is intended for in virro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.

Ariol™ is an automated scanning microscope and image analysis system.

The Applied Imaging Ariol™ is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This Hersight application is intended for use as an accessory to the HercepTest™ (DAKO USA, Carpinteria, CA) and is intended to provide semi-quantitative immunohistochemical (IHC) results to aid in the determination of HER-2/neu (HER2) over-expression in breast cancer tissues routinely processed for histological evaluation. When used with DAKO HercepTest, 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 HercepTest to Herceptin clinical outcome has not been established. The Ariol system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the DakoCytomation HercepTest to assure the validity of the Ariol-assisted HER2 score.

The Applied Imaging Ariol™ is an automated scanning microscope and image analysis system.

WinSCAN is an automated imaging system that scans peripheral blood smears for nucleated blood cells. WinSCAN software provides for operator interaction and decision making to identify nucleated red blood cells (nRBC), and enumerate them as #nRBC/100 white blood cells (WBC).

The WinSCAN System is an automated imaging system that scans peripheral blood smears for nucleated blood cells. WinSCAN software provides for operator interaction and decision making to identify nucleated red blood cells (nRBC), and enumerate them as #nRBC/100 white blood cells (WBC). The operator selects the recommended parameters for nucleated cells, starts the scan and can walk away. The system locates and stores color images of the nucleated cells for each slide, the operator reviews the data on the WinSCAN monitor, and classifies the nucleated cells as nRBC or WBC based on stain and nuclear characteristics. Identification parameters include light adsorption, size and shape. Automatic relocation, capture and archiving of the cell images are performed by the instrument based upon operator selection. The instrument also can be used in the manual mode to systematically scan a slide and examine each field. The WinSCAN System consists of the following components: - Intel-based PC with Windows operating system . - Monitor, kevboard, mouse . - Switchstick control unit t - Color printer for images and texts . - Microscope with brightfield capability and 10x, 20x, 40x and 50x . objectives - Set of transmission and excitation filters . - Camera and image acquisition board t - Motorized devices: stage, filter wheels, focus drive 0 - Motor controller unit and manual controls . The Intel-based PC operates the instrument through the software program that coordinates control of the automated microscope. The base operating system of the PC consists of MicroSoft Windows 3.1 and DOS version 6.0. When the WinSCAN icon is selected from the Program Manager, WinSCAN software is downloaded and operation of the system can begin. The WinSCAN program includes all facilities to scan, relocate, and acquire images from a microscope slide. The WinSCAN software also performs image acquisition and scan functions, as well as archiving and relocation of images and facilitates operator review of cells. Classification of cells is performed by the operator. The Monitor. Kevboard, Mouse, and switchstick control unit provide user interfaces to the system. The monitor displays all information to the user, including menus for navigating through the WinSCAN operation, image acquisition results and allows for operator visual review for operator classification of the nucleated cells found on a slide. The keyboard allows for user entry of scan parameters, slide numbers, user identification, comments, and annotation of results. The mouse/keyboard is used to interact with the instrument and software, including selecting menus and functions of the WinSCAN software and instrument. A color printer is included with the system that allows the user to print results of scanning or acquired images of cells.