BIOVIEW and ANGLE PLC have opened up “a major market opportunity” with breast cancer partnership. Watch the interview with Dr. Alan Schwebel, BioView’s CEO.

ANGLE Announces Partnership With BioView to develop a liquid biopsy circulating tumor cell (CTC) HER2 assay for breast cancer, 19 April 2023

ANGLE plc (AIM:AGL), (OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce it has signed an agreement with BioView Ltd. (“BioView”) (BIOV.TA) to develop a liquid biopsy circulating tumor cell (CTC) HER2 assay for breast cancer utilising ANGLE’s FDA cleared Parsortix® PC1 Clinical System to harvest CTCs and BioView’s automated microscopy systems and software to detect and assess the HER2 expression and/or gene amplification in CTCs.

BioView develops, manufactures and markets innovative automated cell imaging and analysis solutions and has received FDA product clearance for its fluorescent in situ hybridisation (FISH) application for HER2 analysis of FFPE breast tissue sections, hybridised with Abbott’s PathVysion HER2 DNA probe kit. ANGLE has already successfully integrated BioView’s technology in its R&D and clinical laboratories for assay development and pharma services.

ANGLE and BioView will now begin the programme of developing a HER2 assay for the detection of HER2 protein via immunofluorescence (IF) and HER2/neu gene amplification by FISH, utilising Abbott’s PathVysion HER2 DNA probe kit, in CTCs from breast cancer patients’ blood samples harvested using ANGLE’s FDA cleared Parsortix PC1 Clinical System and analysed using BioView’s automated imaging and analysis technology.

It is recognised that breast cancer can be highly heterogeneous and that HER2 status can change over time. In addition, results from a recent high impact study have revealed that patients categorised with HER2-low breast cancer (and defined as immunohistochemistry (IHC) score 1+ and 2+ and HER2-negative by FISH), can in fact, benefit from new HER2 targeted antibody-drug conjugates, where typical HER2 targeted drugs have previously been reserved for HER2-positive (HER2 IHC 3+ and/or HER2 FISH positive) breast cancer patients. This new understanding is driving the adoption of HER2-low targeted drugs such as ENHERTU® marketed by Daiichi-Sankyo and AstraZeneca.

This changing market dynamic has provided ANGLE and BioView with a major commercial opportunity to develop a quantitative CTC-based HER2 assay, to assess HER2 protein expression and/or gene amplification levels by analysing fluorescence intensities. This would be the only product-based solution on the market for this purpose leveraging both companies’ previous FDA product clearances. Unlike current standard of care tests developed for use on FFPE tissue, a CTC HER2 assay could be used for longitudinal monitoring of HER2 status throughout disease progression, thereby ensuring the patient is targeted for the most appropriate treatment at every stage. The development phase is estimated to take around a year to complete with the assay development work generating c. £1.2 million of revenues for ANGLE.

HER2-low breast cancer accounts for 55% of all breast cancer cases whereas HER2-positive cancer accounts for 25% of cases. The new use of trastuzumab deruxtecan (ENHERTU®) to include HER2-low patients has resulted in analysts predicting up to a US$3 billion annual increase in sales value. Because of market expansion into HER2-low patients, and the need for novel biomarkers enabling ongoing patient monitoring of HER2 status, ANGLE and BioView believe there will be demand from medtech and pharma companies for quantitative CTC-based HER2 detection assays to enable regular and accurate stratification of patient populations.

About ANGLE plc www.angleplc.com

ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE’s proven patent protected platforms include a circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.

ANGLE’s cell separation technology is called the Parsortix® system, and it enables a liquid biopsy (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all types of CTCs as well as CTC clusters in a viable form (alive). CTCs enable the complete picture of a cancer to be seen as being a complete cell they allow DNA, RNA and protein analysis and the live cells harvested can be cultured. The Parsortix technology is the subject of 24 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide. The Parsortix system has a CE Mark in Europe for the indicated use and FDA clearance is in process for the United States with a 400 subject clinical study and associated analytical studies in metastatic breast cancer. ANGLE is seeking to be the first ever FDA cleared CTC harvesting system and only the third ever FDA cleared liquid biopsy test. ANGLE has already undertaken two separate 200 subject clinical studies under a program designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (ROC-AUC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimization, and is currently in the process of a 200 patient clinical verification study.

ANGLE’s technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEADTM Ziplex® platform and is based on a patented flow through array technology. It provides for low cost, highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. A proprietary chemistry approach (the HyCEAD method) allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. The HyCEAD Ziplex system is extremely sensitive and is ideal for measuring gene expression and other markers directly from Parsortix harvests and was used in the ovarian cancer pelvic mass triage test to achieve best in class accuracy (ROC-AUC) of 95.1%.

ANGLE’s proprietary technologies can be combined to provide automated, sample-to-answer results in both centralized laboratory and point–of-use cartridge formats.

ANGLE has established formal collaborations with world-class cancer centers and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 28 peer-reviewed publications and numerous publicly available posters, available on our website.

About BioView Ltd www.bioview.com

For nearly two decades BioView has been developing, manufacturing and marketing innovative automated cell imaging and analysis solutions, for use in cytology, cytogenetic, pathology clinical and research laboratories. Founded and managed by experts in the areas of medical devices, clinical and research applications, and automated scanning systems, BioView leverages its knowledge and expertise in the development of a dedicated scanner, designed to address the specific challenges of CTC imaging, analysis and reporting.

BioView is a publicly traded company on the Tel Aviv Stock exchange, and currently has strategic collaborations underway with international scientific leaders and institutions. For more information about the BioView technology, and press related issues, please contact info@bioview.co.il or visit our website at www.bioview.com

Capio Biosciences and BioView Ltd Announce Collaboration to Develop Integrated Workflow for Sample to Answer Assay of Circulating Tumor cells

Capio Biosciences and BioView agreed to launch a joint study to evaluate the performance of an integrated solution of clinical utility making use of Capio Bioscience’s CapioCyte^TM and BioView’s DeNovo^TM systems for the detection and characterization of tumor cells originating from prostate cancer stained with specific tumor related biomarkers.

For more information

BioView and INL spin-off RUBYnanomed start collaboration to improve cancer diagnostics

The International Iberian Nanotechnology Laboratory – INL, its spin-off RUBYnanomed, (Braga, Portugal) a promising company in the field of liquid biopsy, and BioView Ltd., from Rehovot Israel (TASE:BIOV) a provider of automated cell imaging and analysis solutions, announce their collaboration for the development of a custom imaging solution to accelerate the deployment of their circulating tumour cell (CTC) technology in the clinic, in the framework of the CTC-OD project funded by “la Caixa” Foundation.

For more information

BioView and INL spin-off RUBYnanomed start collaboration to improve cancer diagnostics

The International Iberian Nanotechnology Laboratory – INL, its spin-off RUBYnanomed, (Braga, Portugal) a promising company in the field of liquid biopsy, and BioView Ltd., from Rehovot Israel (TASE:BIOV) a provider of automated cell imaging and analysis solutions, announce their collaboration for the development of a custom imaging solution to accelerate the deployment of their circulating tumour cell (CTC) technology in the clinic, in the framework of the CTC-OD project funded by “la Caixa” Foundation.

For more information

Abbott Molecular presents a Multiplex fast FISH assay for detecting ROS1, RET and MET aberrations in FFPE specimens using BioView image analysis, 22-24 June 2020, AACR Posters session

Biomarker testing in lung cancer is often limited by a lack of sufficient formalin fixed, paraffin embedded (FFPE) tissue for comprehensive genomic profiling. To promote personalized therapy for lung cancer, a multiplex FISH assay was developed to simultaneously assess aberrations in ROS1, RET, and MET on a single FFPE specimen slide.

For more information

Introduction of the innovative “MDA TEST” for lung cancer early diagnosis. A session jointly organized by China Lung Cancer Prevention Alliance and Zhuhai Sanmed Biotech Ltd.

The MDA test is a lung nodule blood circulation abnormal cell detection technology, a clinical and practical early screening product for lung cancer. The technology uses fluorescence-labeled in situ hybridization to qualitatively detect the abnormal state of chromosomal mononuclear cells in human peripheral blood to perform auxiliary diagnosis of benign and malignant lung nodules.

View the Webex record chaired by:

Professor Bai Chunxue, Chairman of the China Lung Cancer Prevention Alliance, Director of the Shanghai Institute of    Respiratory Diseases, and Director of the Institute of Respiratory  Diseases of Fudan University

Professor Ruth L. Katz, former Director of Cytopathology at the MD Anderson Cancer Center

Professor Xu Tao, deputy Director of the ward of the Department of Respiratory and Critical Care Medicine from the Affiliated Hospital of Qingdao University

Dr. Ye Xin, University of Illinois, USA, Zhuhai Sanmed Biotech Ltd. Director of Product Development & Assistant General Manager

ANGLE AND BIOVIEW TO PRESENT COMBINED SOLUTION FOR CIRCULATING TUMOR CELL DETECTION AND ANALYSIS AT THE MOLECULAR MED TRI-CON 2020 IN SAN FRANCISCO, 4 MARCH 2020

ANGLE plc, (AIM:AGL OTCQX:ANPCY) a world leading liquid biopsy company, and BioView Ltd. (TASE:BIOV), a provider of automated cell imaging and analysis solutions, announced today that they will present results of their recent collaboration to develop an integrated workflow for identifying clinical biomarkers on circulating tumor cells (CTCs) at the Molecular Med Tri-Con 2020 Conference in San Francisco (Tri-Con) on March 4, 2020.

The collaboration combines ANGLE’s Parsortix system, which enables a liquid biopsy (a simple blood test) to be used to provide the cancer cells for analysis in a format suitable for multiple subsequent downstream analyses, and BioView’s Duet imaging and analysis system, which provides all essential functions required to transform resource-heavy manual CTC detection and analysis into an automated, high-throughput, high-capacity process that is suited to clinical practice. Through the collaboration, ANGLE and BioView are integrating their best-in-class technologies to create a workflow for the isolation and characterization of CTCs with the goal of providing clinical insights to physicians such as the expression of HER-2 (in relation to the drug Herceptin) and PD-L1 (in relation to immunotherapy drugs).

The presentation, “Combining Cell Harvesting and Imaging Technologies for CTC Liquid Biopsy Sample-to-Answer”, will be presented by Anne-Sophie Pailhes-Jimenez, ANGLE Senior R&D Group Leader at Molecular Med Tri-Con 2020.

The Tri-Con Conference is a leading industry event in the personalized medicine space. The upcoming event will focus on emerging therapeutic, diagnostic, and technology approaches to advance precision medicine. The presentation will take place at 12.25 on March 4 in the Muscone South Convention Centre, San Francisco.

ANGLE’s Parsortix system and BioView’s Duet system and associated workflows are available for research use only as products that can be implemented in customers’ laboratories or provided as an ANGLE service with blood samples processed and biomarker information reported.

ANGLE Founder and Chief Executive, Andrew Newland, commented:
“The combination of two leading-edge technologies, ANGLE’s Parsortix CTC enrichment system and BioView’s imaging and detection technology, provides a powerful sample-to-answer workflow for the characterization of CTCs. Such standardized workflows will help support the development of a wide range of clinical applications for CTCs.”

BioView Ltd. President and CEO, Dr. Alan Schwebel, commented:
“We are very pleased to have the opportunity to collaborate with ANGLE. The coupling of the ANGLE Parsortix system and BioView’s Duet imaging and analysis system is an important milestone in bringing Liquid Biopsy CTC analysis to clinical practice.”

About ANGLE plc www.angleplc.com

ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE’s proven patent protected platforms include a circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.

ANGLE’s cell separation technology is called the Parsortix® system, and it enables a liquid biopsy (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all types of CTCs as well as CTC clusters in a viable form (alive). CTCs enable the complete picture of a cancer to be seen as being a complete cell they allow DNA, RNA and protein analysis and the live cells harvested can be cultured. The Parsortix technology is the subject of 24 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide. The Parsortix system has a CE Mark in Europe for the indicated use and FDA clearance is in process for the United States with a 400 subject clinical study and associated analytical studies in metastatic breast cancer. ANGLE is seeking to be the first ever FDA cleared CTC harvesting system and only the third ever FDA cleared liquid biopsy test. ANGLE has already undertaken two separate 200 subject clinical studies under a program designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (ROC-AUC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimization, and is currently in the process of a 200 patient clinical verification study.

ANGLE’s technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEADTM Ziplex® platform and is based on a patented flow through array technology. It provides for low cost, highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. A proprietary chemistry approach (the HyCEAD method) allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. The HyCEAD Ziplex system is extremely sensitive and is ideal for measuring gene expression and other markers directly from Parsortix harvests and was used in the ovarian cancer pelvic mass triage test to achieve best in class accuracy (ROC-AUC) of 95.1%.

ANGLE’s proprietary technologies can be combined to provide automated, sample-to-answer results in both centralized laboratory and point–of-use cartridge formats.

ANGLE has established formal collaborations with world-class cancer centers and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 28 peer-reviewed publications and numerous publicly available posters, available on our website.

About BioView Ltd www.bioview.com

For nearly two decades BioView has been developing, manufacturing and marketing innovative automated cell imaging and analysis solutions, for use in cytology, cytogenetic, pathology clinical and research laboratories. Founded and managed by experts in the areas of medical devices, clinical and research applications, and automated scanning systems, BioView leverages its knowledge and expertise in the development of a dedicated scanner, designed to address the specific challenges of CTC imaging, analysis and reporting.

BioView is a publicly traded company on the Tel Aviv Stock exchange, and currently has strategic collaborations underway with international scientific leaders and institutions. For more information about the BioView technology, and press related issues, please contact info@bioview.co.il or visit our website at www.bioview.com

Angle plc and BioView will be holding a presentation during the upcoming Tri-Con meeting taking place in San Francisco on March 4th, 2020 12:25-12:40 pm.

Presentation title: 

Combining cell harvesting and imaging technologies for CTC liquid biopsy sample-to-answer analysis

Presentation short description: 

Circulating Tumor Cells can provide access to protein and genetic information on patient cancer through a simple blood draw.
Here we share the combination of ANGLE’s Parsortix® system for CTC harvesting with BioView’s automated CTC cell imaging and analysis scanner to deliver robust workflow to support the drive towards precision medicine.

BioView is proud to announce it’s automated metaphase finding as well as G and R band chromosomes classification are now powered by the latest technological breakthroughs in AI and Deep Learning, providing the most comprehensive solution for cytogenetic laboratories. BioView’s Deep Learning algorithms can be be trained by users for specific sub-types of samples,  preparations and qualities to further enhance the laboratory efficiency and accuracy analyzing and reporting cases.

Combined with BioView’s full web review, editing and report capabilities, reinforces BioView’s commitment to develop and introduce innovative image analysis and workflows to improve daily clinical practice.

Abnova and BioView (BIOV:TASE) announced today the launch of  an integrated all-in-one imaging system with artificial intelligence (AI) solution for the identification of circulating tumor cells (CTCs) and circulating fetal cells (CFCs).  This is a culmination of more than a year’s work and close collaboration between two companies to introduce a highly competitive, imaging and smart-algorithm platform for the non-invasive, cell-based liquid biopsy market. During this development period, Abnova and BioView sold several systems in Japan, Taiwan and China which were utilized to test and validate the integrated system.

Going forward, Abnova has the exclusive right to commercialize the all-in-one system with Abnova’s proprietary, cell enrichment instruments, chips, and bioreagents.

Cell-based liquid biopsy is a multi-step, diagnostic process requiring blood sample preparation, cell enrichment, immunostaining, and molecular analysis such as fluorescence in situ hybridization (FISH) and next-generation sequencing (NGS).  The immunostaining and FISH analysis is a critical component of the cell distinction requiring high-speed cell scanning with smart AI coupled with direct sample viewing to accelerate and shorten the cycle time from blood sample to report.  Most scanning microscopes in the market do not have AI capability to analyze the captured images.  Moreover, the scanning microscope does not always have sufficient viewing resolution for final confirmation.

“Imaging and AI is indispensable for cell-based liquid biopsy,” said Dr. Wilber Huang, President of Abnova Corporation.  “They allow us to effectively distinguish each cell’s protein and genomic signature, and more importantly their intercellular heterogeneity and homogeneity.   This foremost identification is first validation step followed by more intensive DNA and RNA validation at greater breadth and depth.  BioView’s solution has catapulted Abnova to become a formidable competitor in the cell-based liquid biopsy market.  We look forward to working with BioView to develop additional turn-key solutions for our customers.”

“BioView’s core competence in imaging and software has the potential to accelerate market adoption of new technologies such as cell-based liquid biopsy,” said Dr. Alan Schwebel, CEO of BioView.  “As the biotech industry is becoming more precision-centric for the patients, BioView is well-positioned to leverage our expertise to provide greater precision on a cellular and even molecular levels.   We are excited to be working with Abnova to rapidly open-up the markets not only for CTCs but also for CFCs from our extensive experiences on FISH probe image analysis. This successful collaboration is  consistent with BioView’s approach to work with leading cell- based liquid biopsy enrichment and assay–labeling partners to advance  the characterization of CTCs into the clinical market.”

About Abnova:

Abnova – a publicly-traded Company on the Taiwan Stock Exchange- has established a comprehensive portfolio of fully integrated solutions to address the needs of the in vitro diagnostic (IVD) industry. Abnova provides its partners and customers access to the technologies, products and services relating to circulating rare cell, circulating exosome, and circulating cell-free RNA for early to metastatic to recurrent disease and treatment diagnosis, prediction, guidance and monitoring. Abnova facility is ISO13485 and GMP certified for proprietary bio reagent and high-throughput automation development and manufacturing for clinical trials and IVD commercialization (www.abnova.com)

Vortex Biosciences, a leading provider of circulating tumor cell (CTC) isolation systems, and BioView Ltd. (TASE:BIOV), a provider of automated cell imaging and analysis solutions, announced a collaboration today to develop an integrated workflow for identifying clinical biomarkers on CTCs.

Tumor biopsies are currently used for identifying diagnostic biomarkers that inform cancer patient treatment. Tumor biopsies, however, are invasive, costly, capture only a select subset of tumor cells in the patient, and are very challenging to perform multiple times during a patient’s treatment to monitor the cancer status in the patient. CTCs offer a better alternative. They are collected from a low cost, non-invasive blood draw, allowing for ongoing monitoring of the cancer status. Furthermore, CTCs enter the blood stream from all of the different tumor sites in a patient, making the sample more representative of a patient’s cancer biology than a tissue biopsy. Vortex Biosciences and BioView are integrating their best in class technologies to create a workflow for the isolation and characterization of CTCs to provide clinical insights to physicians.

The simple to use, fully automated VTX-1 Liquid Biopsy System automates the isolation of CTCs directly from whole blood. The VTX-1 utilizes a proprietary microfluidic chip to stably trap and capture CTCs in micro-scale vortices based on their size and deformability while the red and white blood cells are removed. The isolated CTCs can then be deposited on a specially designed glass slide for analysis. The CTCs adhere to the glass slide with high affinity making characterizing assays like immunostaining or FISH possible.

BioView’s state of the art Duet imaging system and proprietary CTC analysis algorithm automates the identification and biomarker analysis of CTCs on a glass slide. The CTC analysis algorithm was developed in collaboration with leading cancer research centers worldwide, utilizing cellular and biomarker signals to improve the sensitivity and accuracy of CTC detection and reduce analysis time. In order for CTCs to have true clinical utility, an automated, high-throughput system with specialized algorithms for the detection of the cells is critical.

“We are delighted to collaborate with BioView to develop solutions for the clinical characterization of CTCs,” said Gene Walther, Chief Executive Officer at Vortex Biosciences. “A fundamental part of our strategy is to partner with analytical leaders to create integrated workflows that allow for CTCs to become part of the standard of care.”

“We are excited to be working with Vortex Biosciences to move the characterization of CTCs into the clinical market,” said Dr. Alan Schwebel, President and CEO at Bioview. “The imaging platform we have developed will provide the simplicity needed for CTCs to achieve their clinical potential.”

The integrated VTX-1 and BioView workflow is currently being used in several clinical studies focused on CTC enumeration, ALK FISH rearrangements and PD-L1 expression on CTCs. PD-L1, in particular, has been a focus of the collaboration because of the potential clinical benefits. Overexpression of PD-L1 has been identified as a pathway that metastatic tumor cells use to evade immune detection. Immunotherapy based on inhibition of PD-1 or PD-L1 represents a breakthrough in the treatment of advanced cancers. PD-L1 expression levels on tumor biopsies have been demonstrated to be a reasonable biomarker for stratifying patients that will respond better to immunotherapy treatments. Vortex and Bioview believe measuring expression on CTCs can offer more clinical value as it enables monitoring the cancer over time in a cost effective, low risk manner. Vortex and BioView have developed an assay that allows researchers to assess the presence of PD-L1 on CTC surfaces. The belief is that the assay will be able to be used to perform initial diagnoses and to monitor changes in PD-L1 expression during treatment leading to more targeted therapeutic treatment.

The combination of state of the art CTC isolation with CTC specific imaging algorithms opens new paths for the characterization of CTCs to realize their clinical potential.

About Vortex Biosciences:

Vortex Biosciences is a cancer research and diagnostics company that integrates cancer biology, microfluidic engineering and informatics to develop tools for isolating and characterizing circulating tumor cells. The Vortex VTX-1 instrument harvests intact circulating tumor cells from whole blood samples for use in downstream research and clinical applications such as patient stratification in clinical trials, monitoring disease progression and drug treatment effectiveness. With a mission to enable noninvasive diagnosis of cancer and real-time monitoring throughout a patient’s treatment, Vortex is at the forefront of accelerating cancer research and improving patient outcomes. Vortex is a core subsidiary of NetScientific plc, a transatlantic healthcare technology group with an investment strategy focused on sourcing, funding and commercializing technologies that significantly improve the health and well-being of people with chronic diseases. For more information, visit http://www.vortexbiosciences.com.

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

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

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).

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.”

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.

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.

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

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.

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.

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.