Category: Press Releases

San Diego, CA – Visiopharm, a global leader in AI-driven precision pathology, is proud to announce a strategic collaboration with Glint Lab, Inc., a California-based full stack precision pathology laboratory dedicated to preclinical and early-stage discovery. This collaboration with Visiopharm’s Oncotopix Discovery platform elevates Glint Lab’s end-to-end services, reinforcing their commitment to quality and transparency in scientific research. 

Glint Lab turns pathology data into actionable insights, empowering early-stage discovery. Their partnership with Visiopharm provides scientists with best-in-class image analysis and data exploration tools. A key factor in selecting Visiopharm was its unique data exploration capabilities, designed to bridge the gap between quantitative data extracted from the samples and the tissue images. These features allow researchers to connect their findings from quantitative data to spatial insights in the tissue, enabling them to verify hypotheses and gain a deeper understanding of their study. 

Digital pathology is a hotbed for developing the next generation of therapies. By integrating Visiopharm’s advanced AI-driven solutions, Glint Lab is equipped to deliver tailored solutions for unique and novel research questions. Additionally, to enhance their quality control processes, Glint Lab leverages these AI-based solutions to ensure high precision and reproducibility in their results. This ensures that every step of  the pathology workflow at Glint Lab, from tissue analysis to data interpretation, meets the highest standards. 

“Visiopharm is thrilled to strategically collaborate with Glint Lab, a forward-thinking CRO that shares our commitment to quality and innovation. By integrating our Oncotopix Discovery platform, Glint Lab will be able to offer their clients unparalleled precision and insights in tissue-based image analysis,” said Jeni Caldara, Strategic Partnership Manager of Visiopharm. 

“Choosing Visiopharm’s Oncotopix Discovery was a clear decision for us at Glint Lab. Their advanced image analysis platform and unique data exploration tools perfectly align with our mission to deliver high-quality research services and enable our clients to explore tissue-derived data much deeper than they usually would. This partnership will significantly enhance our ability to support our clients’ scientific discoveries,” said Misagh Naderi, Chief Executive Officer of Glint Lab.

About Visiopharm 

Visiopharm is a leading provider of AI-driven precision pathology software for research and diagnostics. In research, it is a technology leader providing tools that help scientists, pathologists, and image analysis experts produce accurate data for all types of tissue-based research. In diagnostics, it is a leader within clinical applications, with no fewer than nine diagnostic algorithms cleared under IVDR for EU and UK customers. These applications provide diagnostic decision support and can be easily activated and integrated into existing lab workflows. Founded in 2002, Visiopharm is privately owned and operates internationally with over 750 customer accounts in more than 40 countries. The company’s headquarters are located in Denmark’s Medicon Valley, with legal entities in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China. 

For more information visit visiopharm.com. 

About Glint Lab 

Glint Lab is a rising CRO dedicated to delivering high-quality, transparent research services. Specializing in histopathology, Glint Lab offers a comprehensive suite of services including tissue processing, sectioning, histochemical staining, immunohistochemistry, immunofluorescence, whole slide imaging, and quantitative image analysis. By integrating advanced image analysis software, Glint Lab ensures that clients receive the most reliable and insightful data to support their scientific endeavors. Their team of experienced histologists and scientists is committed to collaborating closely with clients from study design to data interpretation, ensuring optimal research outcomes. 

For more information, please visit glintlab.com.

Hørsholm, Denmark — Visiopharm, a leader in AI-driven precision pathology, proudly announces a significant achievement. The Pathology Department of the University Medical Center Utrecht (UMC Utrecht) in the Netherlands has validated Visiopharm’s AI application for detecting metastatic breast cancer in lymph nodes in their CONFIDENT-B trial. The AI achieved a remarkable 100% sensitivity for clinically relevant metastases, while at the same time the AI-assisted pathologists spent 39% less time on their assessment compared to reviews without the AI. This advancement promises to revolutionize pathology workflows. 

The UMC Utrecht team’s study, demonstrating the exceptional performance of Visiopharm’s AI APP, has been published in the prestigious journal, Nature Cancer. This publication underscores the potential of AI in transforming cancer diagnostics by showcasing the high sensitivity for clinically relevant metastases, the significant reduction of the need for immunohistochemistry, and the workflow-improvements achieved with Visiopharm’s technology. 

In addition to the publication, UMC Utrecht conducted a comprehensive business case analysis, revealing that the use of Visiopharm’s AI APP results in a positive business case with a significant return on investment. These savings are indicative of the efficiency and financial benefits that AI technology can bring to pathology departments. 

Furthermore, Visiopharm’s AI APP has been seamlessly integrated into UMC Utrecht’s Sectra PACS, creating an automated and efficient workflow for pathologists. Once a slide is scanned, it is automatically analyzed in the background, and the results are available in the Sectra viewer when the pathologist opens the case. This integration ensures that pathologists have immediate access to crucial diagnostic information, streamlining the diagnostic process, reducing turnaround times, and enhancing overall workflow efficiency. 

Prof. Paul van Diest, head of the pathology department at UMC Utrecht, expressed his enthusiasm: “The integration of AI technology into our pathology workflow represents a significant advancement in our diagnostic capabilities. The high sensitivity achieved, along with the substantial cost savings and workflow improvements, underscore the potential of AI in transforming cancer diagnostics. We are currently validating Visiopharm’s AI applications for other indications and the initial results are promising.” 

Dirk Vossen, Chief Diagnostics Officer at Visiopharm, added: “We are thrilled with the results of the UMC Utrecht’s clinical implementation study and the subsequent publication in Nature Cancer. This exemplifies the power of combining cutting-edge AI technology with clinical expertise to enhance diagnostic accuracy and efficiency. The results published validate the earlier work by Anil Parwani that the Visiopharm AI tools provide a positive business case (Challa et al.). We look forward to continuing our partnership with UMC Utrecht and other leading institutions to further advance the field of pathology.” 

This milestone reinforces Visiopharm’s commitment to providing innovative AI solutions that enhance diagnostic precision and operational efficiency in pathology labs worldwide.

Read the full paper here.

Feature photo by Ivar Pel.

For more information, please contact: 

Visiopharm:
Johanne Louise Brændgaard
Chief Marketing Officer
jlb@visiopharm.com

About Visiopharm

Visiopharm is a leading provider of AI-driven precision pathology software for research and diagnostics. In research, it is a technology leader providing tools that help scientists, pathologists, and image analysis experts produce accurate data for all types of tissue-based research. In diagnostics, it is a leader within clinical applications, with no fewer than nine diagnostic algorithms cleared under IVDR for EU and UK customers. These applications provide diagnostic decision support and can be easily activated and integrated into existing lab workflows. Founded in 2002, Visiopharm is privately owned and operates internationally with over 750 customer accounts in more than 40 countries. The company’s headquarters are located in Denmark’s Medicon Valley, with legal entities in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China.

For more information visit visiopharm.com.

About UMC Utrecht: 

The University Medical Center Utrecht (UMC Utrecht) is a leading academic medical center in the Netherlands. UMC Utrecht is dedicated to providing top-tier medical care, conducting groundbreaking research, and offering exceptional education and training for healthcare professionals.

In a groundbreaking collaboration, Visiopharm and the UK National External Quality Assessment Scheme for Immunocytochemistry and In-Situ Hybridisation (UK NEQAS ICC & ISH) are setting new standards in the quality control of IHC testing, harnessing cutting-edge AI technology alongside rigorous external quality assessment.

The need for this initiative is clearly demonstrated in the highly concerning data that reveal 25-30% of laboratories repeatedly fail to meet minimum proficiency standards when testing for critical predictive biomarkers, most often due to false negative results. Given that these tests significantly influence patient treatment decisions, the implications of such inaccuracies are profound.

The alliance introduces a comprehensive toolkit for pathology laboratories, designed to maintain staining quality and align with the latest clinical and regulatory requirements. Visiopharm’s innovative Qualitopix solution enables daily and continuous measuring, monitoring, and documentation of staining consistency/quality, promptly identifying and addressing any deviations. When coupled with UK NEQAS ICC & ISH’s rigorous four-monthly assessments, the laboratory is assured of end-to-end quality assurance monitoring.

Mr. Andy Dodson, Director of UK NEQAS ICC & ISH, highlighted the gravity of the current situation: “The present figures concerning IHC testing accuracy are worrying. The direct link between test precision and patient outcomes cannot be overstated. This joint initiative, combining Visiopharm’s AI-driven internal quality control with our external quality assessment, aims to significantly enhance testing quality, a critical factor in delivering optimal patient care.”

This initiative is poised to redefine industry benchmarks, facilitating laboratories’ adherence to the stringent requirements of the recently revised ISO15189:2022 standard and other regulatory mandates, thereby ensuring superior patient care.

Dr. Michael Grunkin, CEO of Visiopharm, stressed the initiative’s ultimate goal: “At the heart of our mission is patient care. Through this collaboration, we are committed to providing laboratories with the advanced tools necessary for enhancing diagnostic precision. Our joint efforts are expected to play a pivotal role in ensuring patients receive the most effective treatments available.“

About Visiopharm

Visiopharm is a leading provider of AI-driven precision pathology software for research and diagnostics. In research, it is a technology leader providing tools that help scientists, pathologists, and image analysis experts produce accurate data for all types of tissue-based research. In diagnostics, it is a leader within clinical applications, with no less than nine diagnostic algorithms cleared under IVDR for EU and UK customers. These applications provide diagnostic decision support and can be easily activated and integrated into existing lab workflows. Founded in 2002, Visiopharm is privately owned and operates internationally with over 750 customer accounts in more than 40 countries. The company’s headquarters are located in Denmark’s Medicon Valley, with legal entities in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China.

For more information visit visiopharm.com.

About UK NEQAS ICC & ISH

UK NEQAS ICC & ISH is at the forefront of external quality assessment for advanced diagnostic testing in cellular pathology, committed to elevating the standards of IHC and ISH biomarker testing and ensuring adherence to the highest quality and regulatory standards. Founded in 1986, it was one of the first to introduce external quality assessment into clinical cellular pathology. The Scheme is fully accredited to ISO/IEC standards both in the UK and internationally. It operates worldwide, providing a fully comprehensive EQA service to clinical laboratories in more than 50 countries.

For more information visit ukneqasiccish.org.

CND’s Biomarker Testing Services Utilizing Groundbreaking NerValence™ System Unveiled at the AD/PD™ 2024 Parkinson’s and Alzheimer’s Disease Conference

Scottsdale, Ariz – CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today will unveil its NerValence pathology detection system at the AD/PD 2024 conference in Lisbon, Portugal. NerValence, developed through a strategic collaboration with precision pathology company Visiopharm, significantly enhances CND’s biomarker testing services for clinical trials targeting the alpha-synuclein protein in patients with suspected Parkinson’s disease, dementia with Lewy bodies, and related disorders.

“As an expansion of CND’s cutaneous testing services, NerValence is poised to transform the way we identify, quantify, and monitor the misfolded, pathological form of the alpha-synuclein protein in patients,” said Todd Levine, MD, CND’s Chief Medical Officer. “Our work with Visiopharm has demonstrated how innovative digital technology can enhance the detection and measurement of this key biomarker to optimize drug development for Parkinson’s disease and other synuclein-based disorders.”

NerValence features machine learning algorithms that recognize and differentiate microscopic structures, nerves, and important disease markers that can be found in cutaneous tissue. The system was designed and developed by CND in partnership with Visiopharm as a pathology assistance tool for CND’s Syn-One Test^® and is used exclusively by CND pathologists and researchers at the company’s CLIA-certified laboratories in Scottsdale. Syn-One relies on the analysis of skin biopsy samples collected from patients who have signs and symptoms of Parkinson’s disease and related disorders known as synucleinopathies and has demonstrated greater than 95% sensitivity and specificity in detecting phosphorylated alpha-synuclein. Syn-One, as supported by NerValence, is a laboratory developed test (LDT) ordered by neurologists and other clinicians across the US to aid the diagnosis of thousands of patients. NerValence’s unique ability to enhance the identification, tracking, and measuring the volume of alpha-synuclein in cutaneous nerves offers significant benefit in targeting clinical trial patients for the development of disease-modifying therapies.

“Utilizing our novel deep learning technology to power this crucial advancement in neurodegenerative diseases represents a significant leap forward in analyzing peripheral nerves,” said Michael Grunkin, Visiopharm Chief Executive Officer. “Collaborating with CND Life Sciences on its deployment of NerValence will continue to be a major priority as we advance AI-driven precision pathology to enhance biopharmaceutical drug development.”

Stop by our Exhibit Booth #66 at the AD/PD 2024 conference to get a first-hand look at the NerValence system. Also be sure to check out our posters titled “The Synuclein-One Study: Cutaneous Alpha-Synuclein Deposition in Parkinson’s Disease,” Poster Board #0544 and “The Synuclein-One Study: Cutaneous Alpha-Synuclein Deposition in Dementia with Lewy Bodies and Mild Cognitive Impairment,” Poster Board #0561. Both posters will be available for viewing from March 6-7 during designated poster hours.

About CND Life Sciences

CND Life Sciences is dedicated to supporting the care of patients facing the potential diagnosis of a neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND launched the Syn-One Test^® in 2019 as the world’s first commercially available test to detect, visualize, and quantify phosphorylated alpha-synuclein located in cutaneous nerves. This laboratory developed test analyzes three small skin biopsies collected from the patient in a physician’s office through a 15-minute minimally invasive procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic evaluations in the skin. The Syn-One Test is supported by technology licensed from Beth Israel Deaconess Medical Center in Boston and leverages a decade of published science from leading academic institutions in multiple countries. The Company has research collaborations with multiple biopharmaceutical companies and has been awarded three prestigious NIH SBIR grants to advance the validation and clinical utility of its Syn-One Test.  For more information visit cndlifesciences.com or connect with us on LinkedIn.

Disclosure: Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke and the National Institute on Aging (NIA) of the National Institutes of Health under Award Numbers R44NS117214, R44AG076072, and R44NS127696. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Visiopharm

Visiopharm is a leading provider of AI-driven precision pathology software for research and diagnostics. In research, it is a technology leader providing tools that help scientists, pathologists, and image analysis experts produce accurate data for all types of tissue-based research. In diagnostics, it is a leader within clinical applications, with no less than nine diagnostic algorithms cleared under IVDR for EU and UK customers. These applications provide diagnostic decision support and can be easily activated and integrated into existing lab workflows. Founded in 2002, Visiopharm is privately owned and operates internationally with over 750 customer accounts in more than 40 countries. The Company’s headquarters are located in Denmark’s Medicon Valley, with legal entities in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China. For more information visit visiopharm.com.

Contact: 

Lisa DeScenza
LaVoieHealthScience
(978) 395-5970
ldescenza@lavoiehealthsceince.com

SOURCE: CND Life Sciences

Hørsholm, Denmark — Visiopharm A/S, an innovator in AI-powered digital pathology solutions, has announced the IVDR certification of its PD-L1 APP for non-small cell lung cancer (NSCLC). The APP provides fully automated evaluation for the predictive biomarker, offering whole slide analysis results to the pathologist with no prior interaction needed. With exceptional accuracy and consistency in biomarker scoring related to eligibility for immune checkpoint inhibitors, it integrates seamlessly with PACS/IMS systems used by pathology labs, ensuring optimal workflow efficiency.

The APP is the first IVDR-cleared PD-L1 algorithm in the market and expands Visiopharm’s existing diagnostic portfolio for breast, colorectal, and prostate cancer with lung cancer – the second most common cancer type but with the highest number of deaths per year [1]. The product addresses the needs of the current diagnostic market where prescriptions of certain PD-L1 immune checkpoint inhibitors have grown more than 500% between 2020 and 2021 alone [2].  With a growing technology stack for precisely quantifying predictive biomarkers, it shows Visiopharm’s leading capabilities to support the needs of pharma for precision pathology.

Achieving IVDR requires a significant effort, and the PD-L1 APP is the 9^th IVDR clearance for Visiopharm. The validation is based on the results of a comprehensive clinical study encompassing a large patient cohort and evaluations from three distinct European sites. The study directly compared manual assessments with the APP’s stand-alone analysis and APP-assisted interpretations. The results were remarkable, demonstrating substantial to near-perfect agreement with the multi-reader reference score and a high concordance with gold-standard expert manual assessments. Most notably, the data indicates increased agreement rates with pathologists reporting efficiency gains when using the APP, underpinning the fully automated APP’s potential to address the primary challenges of PD-L1 IHC scoring.

Professor Ralf Huss from University Hospital Augsburg, Germany, reflects on the APP’s impact: “After getting acquainted with the APP and building trust in the scores, it was much easier and faster to score PD-L1 NSCLC. It took less than 20 cases doing a site-by-site comparison of the manual scoring with the APP-assisted scores to build up that level of trust. The possibility to interact with the classification and review the image also allows for a very quick plausibility check, if there is some doubt on the APP-generated results, e.g. does the APP only score tumor cells, etc. Now I don’t want to miss the APP anymore to do PD-L1 NSCLC scoring, especially on a larger scale.”

Visiopharm has partnered with Agilent Technologies Inc. to develop and validate the PD-L1 Diagnostic APP adding to its expansive portfolio of fully automated workflow APPs that have been validated using Agilent’s Dako Omnis platform.

Lou Welebob, Vice President and General Manager, Diagnostics and Genomics Group, Agilent comments, “The IVDR certification of Visiopharm’s PD-L1 APP for non-small cell lung cancer (NSCLC) represents a significant advancement in digital pathology. We are excited about the algorithm-assisted advances in pathology scoring and to see how workflow integration may deliver on overall efficiency.”

Dirk Vossen, CDO of Visiopharm, emphasizes the company’s commitment: “Our PD-L1 algorithm exemplifies our drive to refine diagnostic accuracy and support improved efficiencies. Furthermore, it is a product of our fruitful alliance with Agilent.”

See more information on the APP in our APP Center

About Visiopharm

Visiopharm® is a leading provider of AI-driven precision pathology software for research and diagnostics. In research, it is a technology leader providing tools that help scientists, pathologists, and image analysis experts produce accurate data for all types of tissue-based research. In diagnostics, it is a leader within clinical applications, with no less than nine diagnostic algorithms cleared under IVDR for EU and UK customers. These applications provide diagnostic decision support and and can be easily activated and integrated into existing lab workflows.

Founded in 2002, Visiopharm is privately owned and operates internationally with over 750 customer accounts in more than 40 countries. The company’s headquarters are located in Denmark’s Medicon Valley, with offices in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China.

[1] WHO February 2022 (www.who.int)

[2] Shin, Y. ., Kumar, A. & Guo, J.J. Spending, Utilization, and Price Trends for Immune Checkpoint Inhibitors in US Medicaid Programs: An Empirical Analysis from 2011 to 2021. Clin Drug Investig 43, 289–298 (2023)