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BioView
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以色列BioView  
BioView有限公司的使命是成为自动化显微镜检测在癌症的检查和监测实验室设备市场的领导者,提高实验室的生产力,减少了假阳性结果率,使医生和研究人员进行更为准确和更早病人评估。

BioView开发,制造和装配,在细胞学利用市场和服务创新的自动诊断系统细胞,细胞遗传学,血液学和病理学实验室。该公司的旗舰系统由自动扫描成像
BioView 公司发明了一套最先进的全自动扫描图像分析系统DuetTM:它结合形态M(Morphology),免疫组化I (Immuno-Chemistry)和荧光原位杂交FISH 分析技术对每个细胞同时进行两种标记分析

The mission of BioView Ltd. is to become the leader in the laboratory equipment market for cancer screening and monitoring by automating microscopy testing, increasing laboratory productivity, reducing the rate of false-positive results, and enabling physicians and researchers to make more accurate and earlier patient assessments.

BioView develops, manufactures and assembles, markets and services an innovative automated cell diagnostic system for use in cytology, cytogenetics, hematology and pathology laboratories. The company’s flagship system is comprised of an automated scanning imaging


workstation called Duet™, an offline-workstation with proprietary software called Solo™, and preparation kits called BioWhite™, BioRed™ and BioBlue™.
The Duet provides automated detection, classification, analysis, and counting of cells of interest selected for diagnosis and study. The Duet performs bright light illumination scans (to analyze morphology) and fluorescent illumination, utilizing the Fluoresence in-situ Hybridization technique, "FISH", scans (to analyze genetic content) at significantly higher throughputs than currently available equipment. Additionally, the Duet provides a novel method to analyze both the morphology and the genetic content of the same cell. Analysis of the cases and other tasks can be performed on the Solo offline workstation allowing the Duet to scan new cases thereby increasing the laboratory efficiency.

The Company has applications in Cancer diagnosis and follow up of minimal-residual disease (MRD); in pre-natal and post-natal Cytogenetics analyses; in the analysis of sperm cells and rare-cell detection (RCD) capabilities for various applications.

In 2005 the Company introduced two new scanning workstations: the ALLEGRO for automated scanning of FISH probes without Brightfield scanning and the ACCORD for the semi-automated imaging of FISH for Breast Cancer (Her-2/Neu) and for FISH on Tissue.

To date, the Company has received FDA clearance to use the Duet for:

Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension.
Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21.
Cells in urine specimens, stained by FISH using the Vysis UroVysion™ Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p21 locus, from subjects with transitional cell carcinoma of the bladder.
To detect and quantify chromosome 17 and the Her-2/neu gene via FISH in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed by the Vysis PathVysion™ Her-2 DNA Probe Kit.

 

The Company has received the CE mark for its products for marketing in Europe.

BioView’s Quality management (QM) system has been audited by KEMA Quality B.V. The Netherlands, and has received official certification to the ISO 13485:2003 regulatory standards. These regulations are the standards needed for in-vitro diagnostic device (IVDD) manufacturers.

BioView Ltd. is a publicly traded company on the Tel Aviv Stock Exchange (Tel Aviv, Israel). The Company, which started operations in 2000 is headquartered in Rehovot, Israel and has a fully owned subsidiary in the Unites States for the sales and support of our products in North America. The Company’s founders and senior executives have extensive experience in the development and marketing of medical devices and biotechnology applications, including diagnostic equipment with vision applications.

The Company began to market its Duet system in 2003 and has sold dozens of systems to leading University Hospitals, large commercial laboratories and other institutions in the United States and Europe. BioView’s proven record in support of our equipment has lead to many repeat sales to the same customer as their test volumes increased.

The Company is developing other applications for cancer screening and diagnosis and intends to have several novel applications available in 2007/8

 

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