Insight

Insight by Visiopharm is an AI-powered digital pathology platform delivering IVDR-certified diagnostic decision support for clinical laboratories and pathology departments. Designed to address the growing pressures of high case volumes, complex biomarker scoring, and the limitations of manual visual assessment, Insight provides fully automated, reproducible tissue analysis that integrates seamlessly into existing laboratory workflows across the EU and UK.

By combining the largest portfolio of CE-IVD certified APPs with zero-click automation, Visiopharm enables pathologists to move beyond manual counting and eye-balling, focusing instead on confident diagnostic decisions. The platform is built for pathologists, lab administrators, and IT teams alike, with a decade of clinical implementation experience behind every deployment.

IVDR Certified APP Portfolio

• PR APP for Breast Cancer (#90003) — progesterone receptor quantification
• Ki-67 APP for Breast Cancer (#90004) — proliferation index scoring
• Metastasis Detection AI (#90159) — automated lymph node metastasis detection
• ER APP for Breast Cancer (#90002) — estrogen receptor quantification
• Hot Spot (#20114) — automated hot spot identification
• Invasive Tumor Detection PDS (#20101) — detection of invasive tumor regions
• PCK VDS Tumor Detection (#10165) — pan-cytokeratin-based tumor detection
• PD-L1 APP for NSCLC (#90183) — PD-L1 scoring in non-small cell lung cancer
• HER2 APP for Breast Cancer (#90007) — HER2 scoring with reduced inconclusive results
• CE-IVD APPs are certified for in vitro diagnostic use in the EU and UK; translational APPs are available for the USA
• Visiopharm holds the only full portfolio of clinical APPs certified under IVDR, with leadership in this space since 2022

Clinical and Diagnostic Benefits

• Enhanced sensitivity on prognostic and predictive biomarkers to improve patient outcomes and minimise false negative cases
• Higher accuracy and reproducibility than manual visual assessment, providing objective measurement relative to diagnostic cutoffs
• Proven higher sensitivity for lymph node metastasis and HER2 scoring, reducing the need for reflex testing and additional IHC stains
• At UMC Utrecht, use of the Lymph Node Metastasis Detection APP in a fully automated workflow reduced slide review time by over 35% (3:41 min vs. 6:04 min per case), cut unnecessary IHC use saving up to €3,000 over 16 weeks, and maintained or improved sensitivity for micro metastases
• At Vejle Hospital, Denmark, the HER2 APP reduced inconclusive (2+) cases requiring HER2-FISH reflex testing, saving at least one additional day and approximately €250 per test

Efficiency and Cost Savings for Laboratories

• Reduced slide review time frees pathologists to handle greater case volumes
• Decreased reflex testing allows faster case sign-off, benefiting both patients and workload management
• Reduction in expensive secondary stains such as IHC and HER2-FISH lowers direct laboratory costs
• Frees experienced laboratory personnel from repetitive tasks, allowing reallocation of resources to higher-value activities
• Maintains or improves diagnostic sensitivity while delivering measurable cost and time savings

Workflow Integration and Automation

• Fully automated zero-click APPs — results are ready for review with no manual interaction required; the entire slide is evaluated automatically
• Compatible with existing digital IMS/PACS environments, minimising disruption to established laboratory processes
• Flexible deployment options including web-based, on-premises, and hybrid configurations
• Integrations with leading platforms including Proscia, Sectra, PathAI, Philips, Smart in Media, Fujifilm, Corista, Paige, and more
• Standalone access available through slide scanner connectivity for labs not yet fully integrated into a digital IMS/PACS

Implementation Support and Hardware

• Dedicated support team with experience across hospitals and laboratories throughout Europe, ensuring rapid and reliable deployment
• Every installation is treated individually, with technical experts who have a track record of successful real-world integrations — not pilots
• Visiopharm has been delivering IVD-certified APPs since 2014, accumulating over a decade of clinical digital pathology expertise
• In Europe, Visiopharm offers in vitro diagnostic use slide scanners, including Visiopharm Scanners by Hamamatsu, providing fast and reliable whole slide imaging ready for AI-powered image analysis

Insight is designed to meet the regulatory, operational, and clinical standards required for routine diagnostic use in European pathology settings. With IVDR certification, broad system integrations, and a proven track record of real-world deployment, Visiopharm positions Insight as a comprehensive solution for laboratories seeking to standardise biomarker quantification, reduce costs, and support precision medicine at scale.