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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.”

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.”