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The PATHIAM System is intended as an aid to the pathologist to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape, using appropriate controls to assure the validity of the scores. The p53 results provided by the PATHIAM System are indicated for use for the identification of p53 accumulation in human neoplasias when used with IVD reagents marketed for this indication. Interpretation should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. The pathologist must verify agreement with the PATHIAM score. Ki-67 results provided by the PATHIAM System are indicated for use to assess proliferative activity when used with in vitro diagnostic reagents marketed for this indication. Interpretation should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. The pathologist must verify agreement with the PATHIAM score.

The PATHIAM™ System is an instrument and software system designed to assist the qualified pathologist in the consistent quantitative assessment of protein expression in immunohistochemically stained histologic sections from formalin-fixed, paraffin-embedded normal and neoplastic tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse, image analysis algorithms for specific immunohistochemical markers, and software with a Windows web browser-based user interface. PATHIAM is a web-based, end-to-end digital pathology software solution that allows pathology labs to acquire, manage, view, analyze, share, and report on digital images of pathology specimens. Using the PATHIAM software, the pathologist can view digital images, add annotations, make measurements, perform image analysis, and generate reports. The iScan slide scanning device captures digital images of formalin-fixed, paraffin-embedded tissues that are suitable for storage and viewing. The device includes a digital slide scanner, racks for loading glass slides, computer, scanner software, keyboard, mouse and monitor. The PATHIAM software is designed to complement the routine workflow of a qualified pathologist in the review of immunohistochemically stained histologic slides. It allows the user to select fields of view (FOVs) in the digital image for analysis and provides quantitative data on these FOVs to assist with interpretation. The software makes no independent interpretations of the data and requires competent human intervention at all steps in the analysis process.

PATHIAM-Assisted Scoring: Intended for clinical laboratory use as an accessory to the DAKO HercepTest to aid in the detection and semi-quantitative measurement of Her2/neu in formalin fixed, paraffin-embedded normal and neoplastic tissue. When used with the DAKO HercepTest, Pathiam Assisted Scoring is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN (Trastuzumab) treatment is being considered. The pathologist should verify agreement with the PATHIAM System score. HER2/neu results are indicated for use as an aid in the management, prognosis and predication of therapy outcomes of breast cancer. Note: The actual correlation of the DAKO HercepTest to Herceptin® clinical outcome has not been established.

The PATHIAMIM System is an instrument (iScan) and image analysis software system designed to assist the qualified pathologist in the consistent quantitative assessment of marker expression in immunohistochemically stained histological sections digital images. The sample tissue is breast tissue prepared using the DAKO HercepTest Reagent Kit. The PATHIAM system consists of the BioImagene iScan slide scanner, computer with the PATHIAM Software, monitor, keyboard and mouse. The PATHIAM System digitizes formalin-fixed, paraffin embedded normal and neoplastic tissue and provides semi-quantitative analysis of extent and intensity of stained tissue, providing the pathologist with an aid to interpretation of the level of expression of HER2/neu in breast cancer tissue. The pathologist is presented with a digital image of the tissue section and a suggested staining score (0 to 3). The pathologist then makes an assessment of the digital image and reports his/her score. Alternately, the pathologist can simply use the digitized image to perform his interpretation of the level of expression, without employing the software. Hardware: The iScan slide scanning device captures digital images of formalin-fixed, paraffin-embedded tissues that are suitable for storage, viewing and visual analysis. The device includes a digital slide scanner, racks for loading glass slides, an Intel based PC, dual core, dual Xeon processor, PATHIAM Software, and a monitor. Software: The PATHIAM Software requires competent human intervention at all steps in the analysis process. The system is designed to complement the routine workflow of a qualified pathologist screening the immunohistochemically stained histological slides with additional quantitative data to assist the reproducibility of the slide interpretation. It allows the user to select the area of interest on the breast tissue image. The user marks the area of interest for the analysis. The system software makes no independent interpretations of the data. The software will act as a tool for the user, to improve consistency and data recording. The image produced digitally may also be used independent of the software, by allowing the pathologist to count from the digital image, rather than from the microscope.

Biolmagene PATHIAM is intended for use as an accessory to the Dako HercepTest® to aid a pathologist in semi-quantitative measurement of HER2/neu (c-erbB-2) in Formalin-fixed, paraffin-embedded breast cancer tissue. When used with the Dako HercepTest it is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) treatment is being considered. The imaging software is intended to detect and classify cells of clinical interest by analyzing digitized images of microscope slides based on recognition of cellular objects of particular color, size and shape. The software can be used with a computer and image digitizer with features specified in the labeling.

PATHIAM software is a standalone software application that will work on a system with the following features required but not provided: Computer - Processor: 2.4 GHz, Pentium IV equivalent - Memory: 512 MB RAM - Operating System: Windows 2000 or later - Hard Drive: minimum 100MB for software installation, 20GB for image storage - LAN connectivity, minimum 100 MBPS (recommended), support for USB interface, support for HTTP, TCP/IP protocols (using the Operating system) - High Speed Graphic Accelerator Card (1024 X 768) - 17" High resolution display monitor - 24 bit color depth - Font Setting: Small font (DPI setting: 96 DPI) Digitizing Equipment: Camera - Resolution: at least 2048 x 1536 pixels - Frame rate: 20 fps@1200 x 768 resolution (6 fps @ 2048 x 1536 resolution) - Sampling Frequency of 6.26 square/um - Compression format: JPEG 2000, BMP, TIFF, JPEG - Color: 24-bit (R. G. B) - Connection to computer Digitizing Equipment: Digital Side Scanner - Input Format: 25X75mm microscope slides - Resolution: 54,000 pixel/inch with 20X objective - Method: Line-scanning - File Format: TIFF/JPEG2000; compliant with TIFF 6.0 standard. - Color: 24-bit (R.G. B) - Connectivity: 100/1000 MBPS Ethernet - Compression format: JPEG 2000, BMP, TIFF, JPEG The software allows both archiving of the digital image, and semi quantitative analysis of extent and intensity of stained tissue, providing the pathologist with an aid to interpretation of level of expression of Her2/neu in breast cancer tissue. The pathologist is presented with a digital image of the tissue section and a suggested staining score (0 to 3). The pathologist then makes an assessment of the digital image and reports his/her score.