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The GenASIs HiPath IHC Family provides image capture, management, analysis, and viewing of specific immunohistochemically stained slides. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape: 1. The GenASIs HiPath IHC Family for HER2 (4B5) is for image capture and analysis applications. This particular system is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2 protein in formalin-fixed, paraffin-embedded breast cancer tissue. This device is an accessory to Ventana Medical Systems, Inc. PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody. The PATHWAY® anti-HER2/ neu (4B5) Rabbit Monoclonal Primary Antibody is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. NOTE: The GenASIs HiPath IHC Family for HER2 (4BS) image capture and analysis applications are adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and semi-quantitative measurement of images from microscope glass slides of breast cancer specimens stained for the presence of HER-2/neu receptor protein. The pathologist should verify agreement with the Image Analysis software application score by reviewing the glass slide under the microscope. The accuracy of the test results on the quality of the immuchistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay used to assure the validity of the GenASIs HiPath IHC Family for HER2 (4B5) image capture and analysis scores. The actual correlation of PATHWAY® anti-HER-2/neu (4B5) to clinical outcome has not been established. 2. The GenASIs HiPath IHC Family for PR (1E2) is for image capture and analysis applications. This particular system is intended for use as an aid to the pathologist in the detection and qualitative measurement of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded breast cancer tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRMTM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRMTM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The GenASIs HiPath IHC for PR (1E2) image capture and analysis applications are adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and qualitative measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The pathologist should verify agreement with the Image Analysis software application score by reviewing the glass slide under the microscope. The accuracy of the test results depends on 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 CONFIRMTM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the GenASIs HiPath IHC Family for PR (1E2) image capture and analysis scores. The actual correlation of CONFIRMTM anti-PR antibody to clinical outcome has not been established. 3. The GenASIs HiPath IHC Family for ER (SP1) is for image capture and analysis applications. The particular system is intended for use as an aid to the pathologist in the detection and qualitative measurement of ER (SP1): protein in formalin-fixed, paraffin-embedded breast cancer tissue. This device is an accessory to the Ventana Medical Systems, Inc. CONFIRMTM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody. The Ventana Medical Systems, Inc. CONFIRMTM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody is indicated for use as an aid in the assessment of ER status in breast cancer patients (but is not the sole basis for treatment). Note: The GenASIs HiPath IHC Family for ER (SP1) image capture and analysis applications are adjunctive computerassisted methodologies for the qualified pathologist in the acquisition and qualitative measurement of images from microscope glass slides of breast cancer specimens stained for the protein. The pathologist should verify agreement with the Image Analysis software application score by reviewing the glass slide under the microscope. The accuracy of the test results depends on the immuohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRMTM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody to assure the validity of the GenASIs HiPath IHC Family for ER (SP1) image capture and analysis scores. The actual correlation of CONFIRMTM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody to clinical outcome has not been established. 4. The GenASIs HiPath IHC Family for Ki67 (30-9) is for image capture and analysis applications. The particular system is intended for use as an aid to the pathologist in the detection and qualitative measurement of Ki67 (30-9): protein in formalin-fixed, paraffin-embedded breast cancer tissue. This device is an accessory to the Ventana Medical Systems, Inc. CONFIRMTM anti-Ki67 (30-9) Rabbit Monoclonal Primary Antibody assay. The Ventana Medical Systems, Inc. CONFIRMTM anti-Ki67 (30-9) assay is indicated for use in assessing the activity of breast cancer tissue. When used with this assay, the GenASIs HiPath IHC Family for Ki67 (30-9) is indicated for use as an aid in the assessment of Ki-67 status in breast cancer patients (but is not the sole basis for treatment). Note: The GenASIs HiPath IHC Family for Ki67 (30-9) image capture and analysis applications are adjunctive computerassisted methodologies for the qualified pathologist in the acquisition and qualitative measurement of images from microscope glass slides of breast cancer stained for the presence of Ki67 protein. The pathologist should verify agreement with the Image Analysis software application score by reviewing the glass slide under the microscope. The accuracy of the test results depends on 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 CONFIRMTM anti-Ki67 (30-9) Rabbit Monoclonal Primary Antibody assay to assure the validity of the GenASIs HiPath IHC Family for Ki67 (30-9) image capture and analysis scores. The actual correlation of CONFIRMTM anti-Ki67 (30-9) Rabbit Monoclonal Primary antibody assay to clinical outcome has not been established.

The GenASIs HiPath IHC Family, including software is designed to assist the qualified pathologist in the consistent assessment in inmmohistochemnically stained histologic sections from formalin-fixed, paraffin-embedded breast cancer tissues. The device consists of a slide capture camera, Microscope, computer, monitor, keyboard, mouse, image analysis algorithms for specific immunohistochemical markers, and software with a Graphic User Interface (GUI). The GenASIs HiPath IHC Family is an intranet-based, end-to-end, digital pathology software solution that allows pathology laboratories, to acquire, manage, view, analyze, share, and report test results of pathology specimens. Using the GenASIs HiPath IHC Family software the pathologist can view captured images, add annotations, make measurements, perform image analysis and generate reports. Hardware: A camera based acquisition device designed to captures bright-field microscope digital images of formalin-fixed, paraffin-embedded tissues that are suitable for storage and viewing. The device includes a digital slide acquisition camera, X-Y Stage with holder adaptor for loading glass slides on a microscope and a workstation including a computer, keyboard, mouse and monitor. Software: The GenASIs HiPath IHC Family 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 for all steps in the analysis process.

The GenASIs ScanView System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern; and shape. The GenASIs ScanView System is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell types: 1. CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe Kit 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. 2. Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, Paraffin embedded human breast cancer tissue specimens with Vysis® Path Vysion™ HER-2 DNA Probe kit. 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 Path Vysion™ 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 5fluorouracil (CAF) chemotherapy. 3. Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysion™ Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus. from persons with hematuria suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer. 4. Gene rearrangements involving the ALK gene (2p23) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, using Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit. The Vysis ALK Break Apart FISH Probe Kit is indicated to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib). The GenASIs ALK System is an accessory to Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit. The GenASIs ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

The GenASIs ScanView System is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters. The system is designed to work with a manual or automated microscope and includes a dedicated, high powered microscope camera combined with state-of-the-art image analysis software for clinical and research oriented image analysis. The system's modular platform enables automation of a wide range of laboratory selected assays in pathology and cytogenetics applications. This flexible solution may be adapted to the advanced automation and workflow needs of any laboratory or research institution. The system includes a fully automated computer-controlled microscope, motorized 9-slide stage and high powered microscope-camera. This platform also comes with a variety of additional components such as oil dispenser, automated fluorescent illumination control and state-of-the-art image analysis software for clinical and research oriented image analysis and automatic robotic slide loading system, enabling high throughput automated slide analysis for a wide range of pathology applications that provides a true "walk-away" functionality, scanning up to 81 slides consecutively without human intervention. These scanning capabilities presented with the GenASIs High Throughput platform offer an efficient way to optimally use the scanning and analysis system for uninterrupted scanning.

The ScanView System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The Scan View is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell lypes: 1. CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe Kit 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. 2. Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with Vysis® PathVysion™ HER-2 DNA Probe kit. 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 Path Vysion™ 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 cyclophosphanide, doxorubicin, and 5fluorouracil (CAF) chemotherapy. 3. Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysion™ Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus, from persons with hematuria suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer. The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

The ScanView is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and sean cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.

The ScanView System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The ScanView is indicated to detect the following cell types: 1. CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Abbott Laboratories, Illinois, U.S.A) 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 2. Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with the Vysis® Path Vysion™ HER-2 DNA Probe kit. The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

The ScanView is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.

The Scan View System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The ScanView is indicated to detect the following cell types: 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 Scan View System is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytogenetics experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.

The FISHView system is intended to be used for karyotyping with realtime microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment. The FISHView system does not locate metaphase spreads; it does not rank the given cells according to quality; nor does it automatically classify chromosomes. In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for storage of FISH multi - dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. The FISHView system does require and relies on the operator to analyze the digitized microscope images.

The FISHView is a modification of the legally marketed (K012103) BANDView system. Digital visualizing, processing and storage of FISH multi dye images has been added to the BANDView original karyotyping features. The FISHVeiw System is a fully integrated digital imaging platform constructed of a microscope, camera, frame grabber and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytological analysis experts can view, manually scan cells and record the image, using both bright field and fluorescent illumination. The acquire images can be enhanced, archived, retrieved and printed.

The BandView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples with all currently applied banding techniques including G-banding and DAPI-banding. All specimens suitable for banding analysis including from amniotic fluid, peripheral blood, chorionic villus, bone marrow, and tissue can be used without limitation to specific diseases. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment. The BandView system does not locate metaphase spreads; it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized microscope images.

The BandView system aids the cytogenetic specialist in the preparation of karyotypes of human cells in their metaphase. By transferring images of chromosome spreads from the microscope to a computer, the labor-intensive manual processing of photographs, data archiving and document preparation is eliminated. Karyotypes are assembled by the operator with the support of the Band View analysis software. The BandView system does not locate metaphase spreads, it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the cytogeneticist to manipulate the digitized microscope images.

An accessory to a Fundus camera providing spectrally resolved images of the retina and optic disc and providing high contrast visualization of the blood vessels.

The Retinal Cube is an accessory to a standard fundus camera which enables the acquisition, processing, and display of spectrally resolved images with high contrast visualization of blood vessels. The Retinal Cube consists of the following three major components. - The imager unit which mounts on a standard fundus camera and actually acquires the ● spectrally resolved images - A controller unit which contains the electronics that control the imager - . A computer which performs display processing and provides the user interface for the system The imager unit produces a three dimensional data set consisting of a spectrum for each pixel. The 'data is processed using an algorithm which takes advantage of the spectral information to produce a two dimensional image containing high contrast visualization of the blood vessels.