Category: Press Releases

Proscia®, a leader in digital and computational pathology solutions, and Visiopharm, a world leader in AI-driven precision pathology software, today announced a strategic partnership to deliver integrated AI-enabled solutions that aim to improve clinical decision making for cancer care. Through the collaboration, the partners will advance the use of AI-enabled solutions to deliver new insights to pathologists for two of the most common cancer diagnoses.

Driven by a growing base of evidence on the economic and clinical benefits of adoption, leading laboratories are increasingly looking to adopt AI in routine practice to optimize operations and improve patient care. In a Nature survey of pathologists, 75% expressed interest in using AI to facilitate workflow and quality improvements, and 80% expected to be using AI by 2028. Powerful computational applications such as Visiopharm’s portfolio of breast and colon solutions have highlighted the role that AI could play in improving diagnosis for an increasingly large portion of lab volume. However, a key barrier to deriving the full value of AI is the lab’s ability to seamlessly integrate this diverse range of applications into routine operations.

Proscia and Visiopharm have joined forces to deliver a unified solution that combines Visiopharm’s suite of CE-IVD* clinical AI applications – including breast IHC markers, breast metastasis detection, and colon metastasis detection – with Proscia’s CE-IVD Concentriq Dx platform** for image-based data and workflow management. Users of Concentriq Dx can now leverage the full suite of Visiopharm’s AI applications directly in the routine workflow, helping pathologists quantify the expression of biomarkers aiming to accelerate treatment decisions for patient care. This marks an expansion of the companies’ existing collaboration integrating AI-enabled solutions which have successfully driven breakthroughs in translational research and advance precision medicine for life sciences companies.

“We are excited about expanding our successful partnership in the research market to include the clinical market,” said Michael Grunkin, CEO of Visiopharm. “With Visiopharm’s commitment to AI-driven Precision Pathology, and Proscia’s commitment to interoperability and digital workflow solutions for pathology labs, this integrated solution combines efficient workflows and support for optimal treatment decisions to our clinical customers.” *

“Our unified solution will equip pathologists with powerful AI applications to quantify expression of biomarkers aiming to significantly improve treatment decisions,” said David West, CEO of Proscia. “Ultimately, this will enable pathologists to fully realize AI’s potential in unlocking insights that remain hidden to the human eye, helping to advance the way we understand and treat disease, driving accuracy in diagnosis, and establishing prognosis and personalized therapies for patients.”

Click here to learn more about how Visiopharm and Proscia are helping organizations to realize the full promise of their digital pathology data.

References

*Visiopharm’s clinical AI IVDs are certified under IVDR in Europe only. These are not for diagnostic purposes in US.

**Concentriq Dx is CE-marked for in-vitro diagnostic use in Europe and available for primary diagnosis in the US during the COVID-19 public health emergency.

About Visiopharm

Visiopharm® is a world leader in AI-driven precision pathology software. Their pioneering image analysis tools support thousands of scientists, pathologists, and image analysis experts in academic institutions, biopharmaceutical industry, and diagnostic centers. AI-based image analysis and tissue mining tools support research and drug development research worldwide, while CE-IVD APPs support primary diagnostics. With the most advanced and sophisticated artificial intelligence and deep learning, Visiopharm delivers tissue data mining tools, precision results, and workflows.

Visiopharm was founded in 2002 and is privately owned. The company operates internationally with over 900 licenses and countless users in more than 40 countries. The company headquarters are in Denmark’s Medicon Valley, with offices in Sweden, England, Germany, Netherlands and United States.

About Proscia

Proscia is a software company that is accelerating pathology’s digital transformation to change the way we understand diseases like cancer. Its Concentriq digital pathology platform and powerful AI applications are advancing the 150-year-old standard of research and diagnosis towards a data-driven discipline, unlocking new insights that accelerate discovery, improve patient outcomes, and fulfill the promise of precision care. Leading diagnostic laboratories and over 10 of the top 20 pharmaceutical companies rely on Proscia’s software each day. For more information, visit proscia.com.

Visiopharm, a world leader in AI-driven precision pathology software, today announced Oncotopix® Discovery, a solution for tissue-based cancer research. This makes the most recent advances in AI and deep learning available as part of a comprehensive research platform. 

Oncotopix Discovery is designed for all researchers and allows users to tackle both simple and the most complex datasets, to generate reliable quantitative results needed for breakthrough discoveries and publications.

Oncotopix Discovery provides:

Deep learning for all

Easy to use AI deep learning is now integrated as standard in all analysis packages for all tissue research applications.

See it, Train it, Find it

Anyone with an understanding of tissue morphology can train an AI deep learning APP to get accurate and reproducible results.

Pre-trained knowledge

New analysis packages include powerful pre-trained nuclei segmentation APPs suitable for brightfield and fluorescence applications which can be further tuned for even more specificity.

Best-in-class platform

Powered by Visiopharm’s best-in-class image analysis platform, combining 20 years of tissue expertise with innovative state-of-the-art technology.

Dirk Vossen, Visiopharm Chief Diagnostics Officer said:

“We’ve learned from our customers that although many recognise our software as best in class, particularly for demanding applications, there was an overall impression that the software was sometimes difficult to navigate and use. Therefore, it was best suited for use by experienced image analysis experts. We listened, and we have created Oncotopix Discovery, putting deep learning at the base of everything we provide. It means anyone, irrespective of their experience with image analysis software, can now get what they need from the best-in-class digital pathology image analysis solution.”

Louise Armstrong, Visiopharm Chief Commercial Officer said:

“Oncotopix Discovery enables users to get accurate and reliable results across a wide range of research applications including cancer research and neuroscience. Any user that understands cellular and tissue morphology can annotate slides to train our deep learning networks. By combining the researcher’s scientific knowledge with our tissue analysis expertise, anyone can generate the robust quantitative data needed for research studies and publication. We can’t wait to help a new group of biologists, medical researchers and pathologists accelerate their breakthroughs with Oncotopix Discovery.”

Learn more about Oncotopix Discovery.

About Visiopharm

Visiopharm® is a world leader in AI-driven precision pathology software. Their pioneering image analysis tools support thousands of scientists, pathologists, and image analysis experts in academic institutions, biopharmaceutical industry, and diagnostic centers. AI-based image analysis and tissue mining tools support research and drug development research worldwide, while CE-IVD APPs support primary diagnostics. With the most advanced and sophisticated artificial intelligence and deep learning, Visiopharm delivers tissue data mining tools, precision results, and workflows.

Visiopharm was founded in 2002 and is privately owned. The company operates internationally with over 900 licenses and countless users in more than 40 countries. The company headquarters are in Denmark’s Medicon Valley, with offices in Sweden, England, Germany, Netherlands and United States.

Visiopharm, a world leader in AI-driven precision pathology software, today announced that its existing portfolio of diagnostic apps have all been certified under the new In Vitro Diagnostic Regulation (IVDR).

The major difference between the IVDD and the IVDR is the focus on performance evaluation and post market follow up. It’s not new that the safety, effectiveness as well as all product claims need to be substantiated with evidence. What is new, is the technical documentation review is focusing on whether the evidence is scientific and sound. As far as known, Visiopharm is the first digital pathology company to have their IVD devices certified under the IVDR.

Esther Abels, Chief Clinical and Regulatory Officer, Visiopharm said:

“This certification shows that we have our processes in place to ensure we deliver quality products to the clinical field. It is an important milestone in our continuous effort to support the pathology community to enhance capabilities in precision pathology with the goal to optimise patient care. In addition, this milestone is a stepping stone for our entry into the US market.”

Michael Grunkin, CEO, Visiopharm said:

“We have long had a strong strategic focus on AI-driven precision pathology supporting optimal treatment decisions based on companion-diagnostic tissue biomarkers. This includes development and deployment of integrated computational assays for standardisation through decision support and stain quality management. Regulatory approvals is a core-component of that strategy, and we are extremely proud to be the first digital pathology company, to the best of our knowledge, to announce that all our clinical apps are now certified under the new legislation. Our integrated computational assays are currently deployed on our diagnostic enterprise solution for fully digital pathology labs. Qualitopix will shortly introduce these apps on a novel diagnostic platform for partially digital pathology labs.”

Visiopharm today announced that Jeannett Hvidkjær has been appointed to its board.

Hvidkjær brings extensive experience from her current position as CEO and Group CFO in LTP Group A/S – a privately held, global business and manufacturing partner for demanding Sport & Outdoor Garments and Contract Furniture brands – as well as her previous position for thirteen years as EVP, CFO for Cooper Surgical Denmark (Origio A/S) – the global leader in IVF and reproductive genetics and part of The Cooper Companies (S&P 500; Symbol COO).

Hvidkjær started her professional carrier in audit services with EY. Hvidkjær has a broad strategic expertise, an international perspective and in-depth knowledge in various areas, within finance and accounting, M&A, establishment of international operations, as well as compliance and risk management.

Hvidkjær holds a bachelor in Business Economics and Accounting, and certificates from INSEAD for Executive Management Programme in Strategy, Innovation and Leadership and Executive Board Programme, as well as various compliance trainings.

Jeannett Hvidkjær said:

“Visiopharm is a unique company with a comprehensive experience and knowledge in AI-driven precision pathology. The technology effectively addresses critical needs in cancer diagnostics and drug development research. I look very much forward to supporting the company in realising its ambitions and I consider it to be a great responsibility and a privilege to become part of Visiopharm’s journey onwards in the market for AI-driven digital pathology solutions.”

Michael Grunkin, CEO, Visiopharm said:

“Strengthening the board with the competencies Jeannett represents, is very timely as we are embarking on a next phase of our journey. The collaboration is already off to a strong start, and I very much look forward to benefit from her extensive financial experience as we continue to scale.”

Visiopharm today announces that Morten Frost has been elected to Visiopharm’s board. Frost was previously announced as board member elect in April 2021.

Frost brings significant strategic consulting, mergers and acquisitions, and global sales and marketing leadership experience. He is currently Chief Commercial Officer at Veracyte, a pioneering genomics diagnostics company based in South San Francisco, California, US, having been promoted from senior vice president and general manager, pulmonology and breast cancer.

Prior to Veracyte, Frost worked at Agilent Technologies in a variety of leadership positions. Most recently he served as head of global marketing in the pathology and companion diagnostics business, which are part of Agilent’s diagnostics and genomics group. Morten held multiple other positions at Agilent including executive positions in the global diagnostic sales organization and working with strategy and business development, focusing on organic and inorganic investments to expand the diagnostic business.

Before Agilent, Frost was a management consultant at IMS Consulting Group (now IQVIA), where he advised leading pharmaceutical companies on top-line growth and commercial strategy.

Morten Frost said:

“Visiopharm is a unique company with a comprehensive experience and knowledge in AI-driven precision pathology. I’m delighted to have been officially appointed member of the board after participating as board observer since April last year. I have had the pleasure to work closely with the executive team and I continue to be amazed by their unique understanding of the clinical unmet needs, superior technical competencies, and the ability to translate these into concrete applications serving the expansive customer base around the world. The demand for digital pathology solutions has never been greater and Visiopharm is uniquely positioned to serve the research segment as well as drive the adoption of novel diagnostic apps into the routine clinical setting.”

Michael Grunkin, CEO, Visiopharm said:

“We’re excited to welcome Morten to the board having served as board member elect since the Spring last year. He has been providing significant input already and is a great asset as we continue our journey in the clinical pathology space.”

Visiopharm, a world leader in AI-driven precision pathology software, today announced that it has passed an important milestone as it progresses towards its goal of getting their existing portfolio of diagnostic APPs certified under the new In Vitro Diagnostic Regulation (IVDR).

The In Vitro Diagnostic Medical Devices Regulation of 2017 bring EU legislation into line with technical advances, changes in medical science and progress in law-making. The new regulations will create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals.

Visiopharm have successfully renewed their ISO 13485 certificate, passed IVDR audit and technical documentation review, and as such are now recommended for their IVD-CE certificate, covering all eight of their diagnostic APPs.

Esther Abels, Chief Clinical and Regulatory Officer, Visiopharm said:

“We’re really pleased to have our ISO 13485 certificate renewed and now be recommended for IVDR certification. We are one of the first companies to achieve this milestone which is an important step for our continued leadership in precision pathology using AI. We will maintain a strong focus over the coming months to ensure we remain on track to achieve our goal to transition our IVD-CE devices from IVDD into IVDR as well as preparing for entering the US market. I would like to thank the team for their tremendous efforts particularly during this challenging Covid time.”

Michael Grunkin, CEO, Visiopharm said:

“This is an important milestone as we continue to expand our presence as a leader in AI-assisted precision pathology within decision support and standardisation. Product quality is a direct link to patient outcomes. We are pleased to see our continued investments and commitment to quality are enabling us to take a lead in the new regulatory environment reflected in the quality demands that IVDR introduces. I want to recognise the excellent work and dedication of the team in achieving this goal.”