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The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape. In this software application the ACIS is intended for laboratory use as an accessory to the DakoCytomation HercepTest™ to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin embedded normal and neoplastic tissue. The ACIS is capable of detecting and quantifying regions of clinical interest in immunocytochemically stained material that would otherwise be appropriate for manual visualization by conventional microscopy. When used with the DakoCytomation HercepTest™, it 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 ACIS score. The ACIS system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscopic slides of breast cancer specimens stained for the presence of Her2 receptor protein. The accuracy of the test result depends upon the quality of immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in instructions for DakoCytomation HercepTest™ to assure the validity of the ACIS-assisted Her2 score. NOTE: All of the patients in the HERCEPTIN® clinical trials were selected using an investigational immunohistochemical clinical trial assay (CTA). None of the patients in those trials were selected using the DakoCytomation HercepTest™. The DakoCytomation HercepTest™ was compared to the CTA on an independent set of samples and found to provide acceptably concordant results. The actual correlation of the DakoCytomation HercepTest™ to HERCEPTIN® clinical outcome has not been established.

The ACIS is a highly automated microscope and software system capable of operating continuously with limited human supervision and maintenance. By automating certain steps of the basic microscopic procedure (loading, positioning, focusing, scanning, and cell identification and quantification), the ACIS can significantly improve the consistency, speed, reproducibility, and accuracy of traditional manual or semi-manual laboratory results. The ACIS can automatically scan and process up to 100 slides while operating unattended. As each slide is processed, the system automatically stores individual fields of view in order to map and integrate this into a single image, a histological reconstruction of the entire tissue section. The proprietary software-based digital color detection technology offers significant sensitivity and specificity to identify targeted cells using common laboratory stains. This technology utilizes advanced imaging concepts referred to as "color spaces" and "color space conversion." During normal operation, a laboratory technician mounts prepared microscope slides onto a specially designed slide carrier which has the capacity to hold up to four slides. Up to 25 slide carriers can be loaded into the ACIS slide transport system, for a "run" throughput of 100 slides. The scanning process begins with the automatic loading of the first carrier of slides onto the microscope stage. During this stage of the process, the ACIS automatically reads bar codes affixed to the slides to facilitate participant data storage and access. During scanning, the ACIS automatically focuses each field of view, images the object using the CCD camera, and processes the resulting digital image through the image processor. Slides are then scanned at a low optical magnification (typically 4X objective) to find regions of interest based primarily on their color, along with size and shape characteristics. The locations of regions are stored until scanning is completed. Once the region of interest containing the specimen is found, a scan of the specimen commences to build a low power image of the specimen (histological reconstruction). For the HER2 assay, the ACIS creates the histological reconstruction. The pathologist may then visit any area of the scanned tissue section at low or high magnification. The pathologist electronically selects regions of invasive carcinoma. The scoring is expressed as intensity of brown color within the stained cells in the selected area. After scanning is completed, the operator is able to view the histological reconstruction of all stored images for interpretation of the detected objects, along with quantitative information, such as the number of objects detected and colorimetric value. Upon completion of this review, a report containing relevant images identified by the pathologist may be printed. Images may be saved on the hard drive or archived to removable media.