News

  •  November 2016
    AMP Conference workshop – Utilization of Innovative Web Based FISH Review and Analysis Solution in Daily Clinical Practice
  •  March 2016
    BioView receives TFDA regulatory clearance to market its products in Taiwan Copy

    BioView is happy to announce that it has received the QSD certificate from Taiwanese FDA

  •  December 2015
    Distribution agreement for BioView’s early detection Lung Cancer Test was signed in Australia and New-Zealand

    BioView is happy to announce that it has signed an agreement with Diagnostic Solutions (Australia) for the marketing of the LCD test developed for Australia and New-Zealand.

  •  November 2015
    BioView Receives Chinese FDA Clearance for DUET Automated FISH Imaging Systems

    BioView announced today that it has received clearance from the Food and Drug Administration of the Republic of China (CFDA) for its DUET Automated FISH Scanning and Analysis systems.

  •  September 2015
    BioView non-invasive sputum FISH test receives CE Mark

    BioView is pleased to announce that the DUET system and the company’s proprietary non-invasive sputum FISH probed based test, assisting in early detection of Lung Cancer is compliant to the CE directive 98/79/EEC concerning in vitro diagnostic medical devices. BioView Lung Cancer test CE Marking, enables the product to be marketed …

  •  August 2015
    Big tender award in Asia Pacific

    BioView is pleased to announce that it has received an order from its Worldwide Distributor, Abbott Molecular, for 7 Allegro Plus scanning instruments for 7 Hospitals in a Country in Asia Pacific. This order was received subsequent to Abbott Molecular being awarded a tender from a large Hospital…

  •  May 2014
    BioView receives FDA clearance for ALK FISH application

    BioView is pleased to announce that the United States Food and Drug Administration (FDA) cleared for marketing in the United States…

  •  September 2014
    BioView receives Australian TGA regulatory approval

    BioView is pleased to announce that the DUET system received the Australian TGA regulatory approval.
    The Duet™ system is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnosis use as an aiding tool in the detection, classification and counting of cells of interests based on particular color, intensity, size, pattern and shape.

  •  August 2014
    Development agreement signed

    BioView Ltd. and Abbott have entered into a joint development agreement. Under terms of the agreement, Abbott plans to develop FISH probes for Research Use Only (RUO) and in-vitro diagnostic (IVD) purposes worldwide and BioView will develop software and software applications…

  •  March 2014
    BioView receives Korea FDA approval

    BioView is pleased to announce the receipt of Korean FDA approval for marketing of Bioview’s scanning systems in Korea. Bioview’s cell imaging systems for analysis of cells stained by morphological, immunohistochemical and FISH markers allows automatic scanning…

News

 November 2016

Subhadra Nandula, Ph.D FACMG , Associate Director, Cytogenetics and Molecular Diagnostics, Cancer Genetics, Inc. (CGI)
With the increasing pressure placed on laboratories to digitize laboratory documentation, analysis and reporting, together with the growing need for improved communication between the multidisciplinary experts involved in FISH analysis, the introduction of a dedicated web application provides a solution that bridges the gap between laboratory, pathologist and caregiver.
By facilitating, simplifying and making the test review and analysis processes accessible from any location, analysis review and reporting over standard web browsers improves efficiency and productivity, as well as cooperation between experts. Ultimately, better communication throughout the workflow increases the quality of the reported results.
Learn about the integration and day to day use of a web based solution for automated FISH scanning, analysis and reporting as successfully performed by Cancer Genetics, Inc.
Dr. Nandula will share the implementation process , added value as well as experience shifting laboratory daily activity to a fully digital – automated FISH analysis environment.

Download Presentation

News

 March 2016

BioView is happy to announce that it has received the QSD certificate from Taiwanese FDA

News

 December 2015

BioView is happy to announce that it has signed an agreement with Diagnostic Solutions (Australia) for the marketing of the LCD test developed for Australia and New-Zealand.

As part of the agreement, during the first phase DS will perform a validation trial at one of the most important hospitals in Sydney and in parallel DS will apply to the local authorities for obtaining TGA regulatory approval and reimbursement code. As a second phase DS will purchase and distribute BioView’s imaging system combined with the LCD test kits.

About Diagnostic Solutions:

Diagnostic Solutions was established in 1998 to meet the changing needs of the IVD Pathology Industry in Australia and New-Zealand, by providing leading edge laboratory testing technology supported by a highly trained and professional support and service team.

Diagnostic Solutions is part of Diploma Healthcare Group, which is owned by Diploma PLC, traded in London (DPLM:London).

News

 November 2015

BioView announced today that it has received clearance from the Food and Drug Administration of the Republic of China (CFDA) for its DUET Automated FISH Scanning and Analysis systems.
BioView’s automated imaging and analysis systems are designed to seamlessly ease the analysis, reporting processes and to reduce turn-around time for labor intensive tests performed by cytogenetic, pathology and cytology laboratories. BioView’s wide portfolio of automated platforms ensures proper fit for laboratory needs, by providing solutions for various sample volumes and automation level requirements.

BioView worked closely with its worldwide distributor, Abbott Molecular, in order to receive the CFDA clearance.
“This clearance is a very important milestone for BioView especially in the context of our commercial relationship with Abbott Molecular”, said Dr. Alan Schwebel, BioView’s President and CEO.
“First and foremost BioView’s advanced products will now be available to Chinese laboratories, which will help them increase their productivity and ensure the highest level of patient care.
Of its main competitors in the Chinese market, BioView is the only one which offers CFDA cleared FISH systems.
Secondly, with this clearance BioView’s products now have regulatory clearance in most major world markets, and can be sold by Abbott Molecular in those markets. We continue to work with Abbott to widen our application portfolio and our worldwide commercial marketing activities.”

News

 September 2015

BioView is pleased to announce that the DUET system and the company’s proprietary non-invasive sputum FISH probed based test, assisting in early detection of Lung Cancer is compliant to the CE directive 98/79/EEC concerning in vitro diagnostic medical devices.

BioView Lung Cancer test CE Marking, enables the product to be marketed and sold in Europe and countries that adopted the European regulatory standards under the CE Mark.

News

 August 2015

BioView is pleased to announce that it has received an order from its Worldwide Distributor, Abbott Molecular, for 7 Allegro Plus scanning instruments for 7 Hospitals in a Country in Asia Pacific. This order was received subsequent to Abbott Molecular being awarded a tender from a large Hospital chain in that country. Installation of the instruments is scheduled for Q4-2015. Terms of the sale are not disclosed.

News

 May 2014

BioView is pleased to announce that the United States Food and Drug Administration (FDA) cleared for marketing in the United States its automated scanning microscope and image analysis system, the Duet™ system, to qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, probed with the Abbott Vysis® ALK Break Apart FISH Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image. The Duet™ system is intended for in-vitro diagnostic use as an aiding tool to the pathologist in the detection, classification and counting of cells of interest based on color, intensity, size, pattern, and shape.

The Duet™ had previously received FDA clearances for the following applications: 

  • 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 FFPE breast tissue specimens probed by the Vysis® PathVysion™ HER-2 DNA Probe Kit
  •  FFPE breast tissue specimens probed by the Vysis® PathVysion™ HER-2 DNA Probe Kit

News

 September 2014

BioView is pleased to announce that the DUET system received the Australian   TGA regulatory approval.

The Duet™ system is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnosis use as an aiding tool in the detection, classification and counting of cells of interests based on particular color, intensity, size, pattern and shape.

News

 August 2014

BioView Ltd. and Abbott have entered into a joint development agreement. Under terms of the agreement, Abbott plans to develop FISH probes for Research Use Only (RUO) and in-vitro diagnostic (IVD) purposes worldwide and BioView will develop software and software applications for the automated imaging of the FISH probes on the BioView Duet family of systems. The products resulting from this joint development will be marketed and sold by Abbott in accordance with the Distribution Agreement between the Companies established in July, 2013. Each party will bear its own costs for Assay development (Abbott) and Software development (BioView), unless agreed otherwise.

News

 March 2014

BioView is pleased to announce the receipt of Korean FDA approval for marketing of Bioview’s scanning systems in Korea. Bioview’s cell imaging systems for analysis of cells stained by morphological, immunohistochemical and FISH markers allows automatic scanning, imaging and analysis via Bioview’s unique software. The company has a full range of imaging and offline analysis workstations, including Accord, Allegro+ and Duet-3.

Events

 September 2017
European Congress of Pathology
Amsterdam, Netherlands link
 October 2017
The American Society of Human Genetics (ASHG)
Orlando,  Florida , USA link
 October 2017
College of American Pathologists (CAP)
Maryland , USA link
 November 2017
Association for Molecular Pathology (AMP)
Salt Lake City,  Utah, USA link
 December 2017
The American Society of Hematology (ASH)
Atlanta,  Georgia , USA link