Category: Press Releases

VFFEI Ltd, the global developer of award-winning digital pathology imaging solutions, today announced that their patented Sierra colour calibration technology has been integrated into Visiopharm’s viewer, for AI-based image analysis and workflow. Visiopharm is on a mission to transform pathology through AI and workflow standardisation. Today this goes a step further by enabling pathologists to view digital tissue samples that are standardised to ground truth colour – using scanner agnostic, device-specific ICC profiles.

The ICC profile is seamlessly generated using the recently launched Sierra Validate & Standardise (VS) Profiler. Available as a package, Sierra VS-Profiler comprises of a Sierra slide, Sierra VS-Analyser tool and FFEI’s proprietary algorithm that will generate high-accuracy, device-specific ICC profiles. Specifically, the accuracy of a given scanner is measured using an image of the patented Sierra slide. A unique ICC profile is then generated for that device to be integrated into manufacturing, QA process, AI systems and other workflows.

It is this ICC profile that can now be integrated into Visiopharm’s pathology workflow and will enable all images scanned to remain standardised and of ground truth colour when viewed using the Visiopharm Viewer platform. For pathologists they simply need to upload the ICC profile to Visiopharm.

Dr Rick Salmon commented: “With an increasing demand for standardisation across the digital pathology landscape, we are excited that industry innovators such as Visiopharm are embracing the specific need to standardise colour – incorporating FFEI’s patented Sierra technology, quantitative analysis and high-accuracy ICC profiling algorithm into Visiopharm’s industry-leading viewer.” Dr Salmon continued, “This collaboration represents a first-in-kind, scanner-agnostic solution to a key QA issue for current and future users.”

“With this important milestone for scanner agnostic calibration and troubleshooting, Visiopharm underpins their leading position in the field of digital pathology and becomes the first company supporting FFEI ICC profiling,” said Visiopharm chief technology officer, Johan Doré.

Visiopharm and UK NEQAS for Immunocytochemistry and In-Situ Hybridisation today announced that they have expanded their successful and longstanding collaboration to improve tissue biomarker assessment, with the ultimate goal to increase patient safety. The expansion will give UK NEQAS access to Visiopharm’s Qualitopix platform, which uses AI for objective assessment and increased standardisation for key biomarkers.

Image-based tissue biomarkers provide critical insights for cancer diagnostics and the selection of optimal treatment strategies for cancer patients. Recent breakthroughs in immuo-oncology will further increase the importance of these spatially resolved tissue biomarkers.

A challenge with the use of tissue biomarkers relates to staining quality in diagnostic pathology labs. Insufficient staining quality may lead to incorrect test results, which have significant socioeconomic costs, and consequences for the patient. Furthermore, stain quality also impacts the result of AI analysis, a fact that seems to be largely ignored by the digital and computational pathology community.

Pathology labs manage the quality of these tests using visual inspection of samples and reference tissues, and by participation in quality schemes with External Quality Assessment (EQA) organisations. Leading European EQA organisations, such as UK NEQAS and NordiQC, have documented failure rates in proficiency testing among routine diagnostic pathology labs can be as high as 30% for certain biomarkers.

Dirk Vossen Chief Diagnostic Officer at Visiopharm says: “With Qualitopix, Visiopharm has developed a platform that use the power of AI in combination with standardised reference samples to objectively quantify stain quality. Pathology labs now get insight into fluctuations and trends in their stain quality that have previously been difficult to identify.”

EQA provides labs with an indicator of their proficiency against carefully selected reference standard, and careful review by a panel of objective experts. Such quality programs are offered for a range of important tissue-diagnostic biomarkers labs that are failing proficiency tests are offered stain-protocol review and re-testing. Quality programs offered by EQA’s such as UK NEQAS have demonstrated the ability to improve the pass-rate over time across a larger group of diagnostic pathology labs. While the EQA programs have been very successful, their work is extremely labour intensive and time consuming. They are therefore only able to offer Quality Runs for biomarkers a few times a year.

Andrew Dodson, Director, UK NEQAS for Immunocytochemistry and In-Situ Hybridisation says: “With access to the technology offered by Qualitopix, we will be able to mitigate several of the most time consuming and costly steps and improve both our capacity and the quality of feedback, to the benefit of our participants. We look forward to the collaboration with Visiopharm, making UK NEQAS the first EQA to deploy AI in taking proficiency testing to the next level.”

Visiopharm and UK NEQAS have closely collaborated for close to a decade.

Michael Grunkin, CEO, Visiopharm says: “We are delighted to expand our collaboration to include Qualitopix. Qualitopix can also be used as a collaborative platform between pathology labs and UK NEQAS, whenever there is a need to discuss and seek advice regarding, for example, staining protocols and standardisation.”

Visiopharm is pleased to announce the appointment of Christian Kaltoft as Chief Operating Officer (COO).

Christian joins with over 15 years of experience in the pharma and life science industry. For the last eight years Christian has worked at Agilent Technologies in a variety of leadership positions within Agilent’s cancer diagnostic division. Agilent is a leading company within tissue-based cancer diagnostic and companion diagnostic. Most recently he was director of diagnostic hardware and software portfolio within global pathology marketing.

Before Agilent, Christian held positions in pharma within medical, sales and marketing, which provides Christian with a deep understanding of both the pharma, diagnostic and critical interface that enables precision medicine.

Christian takes over from current COO Thomas Ahl who will retire in the new year. Thomas has been at Visiopharm since February 2018, during which time he contributed heavily to the transformation of Visiopharm into a global and scalable business. “Thomas has been instrumental in transforming Visiopharm into a truly scalable enterprise with global presence, and we are very grateful to him for his role in this critical part of our journey,” said Michael Grunkin, CEO of Visiopharm.

Visiopharm CEO, Michael Grunkin said:

“We are very pleased that Christian is joining us at a time where we are embarking on this next exciting phase of our journey towards becoming a global tissue-diagnostic company. He is bringing a deep understanding of the market needs, where in the tissue diagnostic workflows AI can move the needle on productivity and precision, and from a cross-functional perspective, how Visiopharm can most efficiently deliver on all those parameters.”

Christian Kaltoft said:

“I’m excited to be joining Visiopharm at such a pivotal time. I have evaluated the digital pathology market and the continuous evolution. Visiopharm are one of very few AI companies in the pathology space with a proven commercial track record in the diagnostic market with a footprint of 75 diagnostic pathology labs throughout many countries. I believe that Visiopharm is very well-positioned to lead the next evolution that will enable improved standardization and expand clinical utility of image analysis in routine diagnostic setting.”

Fluidigm Corporation and Visiopharm today announced a new co-marketing programme, to offer Visiopharm® image analysis software for faster and more streamlined analysis of data acquired through Imaging Mass Cytometry™ (IMC™). The programme is the latest phase of an ongoing collaboration between the two companies.

Visiopharm is a world leader in image analysis, with a mission to transform pathology through AI-based image analysis and workflow standardization, offering solutions for digital pathology.

New software developed in collaboration with Visiopharm will enable native reading of data files from the Hyperion™ Imaging System, which uses IMC technology, imported into Visiopharm analysis tools. The new software will be launched at the 2021 Fluidigm IMC Summit on 21 October.

“As part of this latest milestone in our collaboration with Fluidigm, Visiopharm becomes the first company to provide third-party software that enables native reading of Imaging Mass Cytometry data files, with all metadata and imagery intact, eliminating the need for conversion to an intermediate format,” said Visiopharm CTO Johan Doré Hansen. “This simplifies the workflow, enabling faster analysis of cellular phenotypes and their interrelationships within the spatial context of the tissue microenvironment.

“With advanced capabilities for high-plex analysis and subsequent data mining, we believe Visiopharm is the partner of choice for the analysis of Imaging Mass Cytometry data files, and this enhancement will be yet another reason for researchers to choose IMC as the premier tool for uncovering meaningful new insights in health and disease.”

Globally, mass cytometry is utilized by 9 of the top 10 pharma companies. Mass cytometry technologies, including CyTOF®, Imaging Mass Cytometry and Maxpar® Direct™, have been used in more than 160 National Clinical Trials.

“The translational and clinical research testing markets have come to rely upon the Hyperion Imaging System for imaging solutions for biomarker discovery and drug development,” said Chris Linthwaite, President and CEO. “We are excited to partner with Visiopharm to further expand the ecosystem of Imaging Mass Cytometry data analysis tools, which provide valuable insights and advance health care decision making.”

About Visiopharm

Visiopharm® is a world leader in AI-driven digital pathology solutions. Visiopharm’s pioneering image analysis tools support thousands of scientists, pathologists, and image analysis experts in both academic institutions and the biopharmaceutical industry.

AI-based image analysis and tissue mining tools support research and drug development research worldwide, while their CE-IVD APPs support diagnostics. With the most advanced and sophisticated artificial intelligence and deep learning, they deliver tissue data mining tools, precision results, and workflows. Visiopharm was founded in 2001 and is privately owned. The company operates internationally with over 900 licenses and countless users in more than 40 countries. Company headquarters are in Denmark’s Medicon Valley, with further offices in Sweden, United Kingdom, Germany, Netherlands, and the United States.

About Fluidigm

Fluidigm (Nasdaq:FLDM) focuses on the most pressing needs in translational and clinical research, including cancer, immunology, and immunotherapy. Using proprietary CyTOF and microfluidics technologies, we develop, manufacture, and market multi-omic solutions to drive meaningful insights in health and disease, identify biomarkers to inform decisions, and accelerate the development of more effective therapies. Our customers are leading academic, government, pharmaceutical, biotechnology, plant and animal research, and clinical laboratories worldwide. Together with them, we strive to increase the quality of life for all. For more information, visit fluidigm.com.

Fluidigm, the Fluidigm logo, CyTOF, Hyperion, Imaging Mass Cytometry, IMC, and Maxpar are trademarks and/or registered trademarks of Fluidigm Corporation or its affiliates in the United States and/or other countries. All other trademarks are the sole property of their respective owners. Fluidigm products are provided for Research Use Only. Not for use in diagnostic procedures.

Visiopharm has been granted the European patent, Method for labelling histopathological images and training deep learning models, EP3639191. The patent is still pending in the US and other jurisdictions.

For a relatively broad range of applications, the method is addressing one of the most significant bottlenecks in the development of new Deep Learning applications for pathology, which is obtaining training annotations. For such applications, the method will eliminate this rate-limiting, time-consuming, and costly step. An example of the utility of this method is published in Automated Quantification of sTIL Density with H&E-Based Digital Image Analysis Has Prognostic Potential in Triple-Negative Breast Cancers.

Whenever a Deep Learning Network is required to recognize certain structures in stained tissue sections, training typically relies on hand annotations by several experienced pathologists, sometimes followed by an adjudication session for cases with disagreement. Such datasets are inherently noisy, due to unavoidable inaccuracies, concomitantly requiring larger datasets to statistically ‘cancel out’ the noise components.

The method proposed here, can be used whenever the structures of interest can be labeled with IHC, whether it is BF of IF. Structures labeled in this way are typically very easy to segment with image analysis. The regions can then be transferred to either a serial section, or a serially stained section, where they are used as training annotations.

This critical step relies on Visiopharm’s global patent for Virtual Multiplexing method described in the European Patent Office and US, where two or more slides that can be aligned at very high speed and accuracy.

Jeppe Thagaard, head of AI, Visiopharm said:

“This method does not only lower the cost and time of manual annotation, but it also allows us to create training data sets with much higher annotation consistency – one of the most important aspects of developing deep learning-based applications. This, in turn, has the potential to greatly reduce the volume of training data required to achieve sufficient clinical performance of the DL network.”

Johan Doré, CTO, Visiopharm said:

“This is the kind of breakthrough we need to dramatically accelerate the creation of diagnostic decision support- and quality control content for our Image Analysis Management System. The Oncotopix IAMS is scanner agnostic, and also plugs agnostically and directly into any digital pathology workstream, whether it is driven by a LIMS or a PACS.”

Agilent Technologies Inc. (NYSE: A), a leader in life sciences, diagnostics, and applied chemical markets, and Visiopharm, a leader in AI-based digital pathology, today announced the signing of a worldwide distribution agreement, enabling Agilent to co-market Visiopharm’s portfolio of CE-IVD marked artificial intelligence (AI)-driven Precision Pathology software in addition to Agilent’s portfolio of automated pathology staining solutions. With an initial focus on Europe, this agreement marks Agilent’s first entry into the growing digital pathology market and strengthens the relationship between the two companies by further expanding the scope of their long-term collaboration.

Digital pathology is experiencing rapid growth worldwide, with its adoption expected to double by the end of this decade. As the use of digital pathology increases, AI-driven pathology solutions are emerging as the new standard. These solutions can provide diagnostic decision support and productivity enhancements that enable pathologists to improve diagnostic accuracy and workload management.

This adoption has been accelerated by the COVID-19 pandemic, which has found pathologists increasingly reviewing cases remotely. In the United Kingdom, for example, pathologists have received guidance for remote reporting of digital pathology slides in times of exceptional service pressure, and support in the adoption of technologies, such as digital pathology, that have the potential to aid in their assessment.

“This is an exciting next step in our partnership with Visiopharm,” said Lou Welebob, vice president and general manager of Agilent’s Pathology Division. “Being able to offer our customers digital pathology software alongside our range of automated staining solutions is a powerful combination that can support pathologists in their assessment and help improve patient care. We look forward to our continued collaboration with Visiopharm as we work together toward the fully digitalized pathology lab of the future.”

Michael Grunkin, CEO, Visiopharm said: “We’re delighted to further expand our partnership with Agilent. With strong complementary solutions, we will be able to address recognized and currently unmet needs for both standardization and automation. This distrubution agreement is a logical first step towards supporting those labs who share our joint vision of automated AI-driven Precision Pathology.”

Prior to this announcement, Agilent and Visiopharm have collaborated to validate Visiopharm’s existing HER2 APP to include Agilent’s new HercepTest mAb pharmDx for Dako Omnis, both CE-IVD marked and available for sale in Europe. Released in October 2020, this product enables pathologists to use the Visiopharm HER2 APP for objective decision support in the assessment of HercepTest™ mAb pharmDx stained slides, saving valuable time for both pathologists and patients.

For in vitro diagnostic use in Europe.

HercepTestTM mAb pharmDx (Dako Omnis) (Code GE001):

The licensed antibody is created by Epitomics Inc. (an Abcam company), using Abcam’s proprietary rabbit monoclonal antibody technology covered under Patent No’s 5,675,063 and 7,402,409.

HercepTest™ and Herceptin® are trademarks owned by Genentech, Inc.