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Press Releases | September 2, 2025 |

Stratipath and Visiopharm partner to advance implementation of AI-Powered Breast Cancer Diagnostics 

Stockholm, Copenhagen, ScandinaviaStratipath and Visiopharm, two global leaders in AI-based precision cancer diagnostics, today announced a strategic collaboration to combine their regulatory compliant solutions for enhanced breast cancer diagnostics. The joint initiative will be presented at the upcoming European Congress of Pathology (ECP) in Vienna, October 2025.

Over the years, Visiopharm has established itself as a global leader for AI-based biomarker scoring in diagnostic histopathology. Stratipath’s flagship prognostic AI solution, Stratipath Breast, has gained clinical adoption as a cost-efficient, faster alternative to traditional genomic tests for risk stratification of breast cancer patients.

The adoption of digital pathology is accelerating, with increasing recognition of the importance of combining complementary tools to improve and streamline treatment decisions. Numerous scientific investigations have found considerable variability of biomarker and grade assessment in and between pathology laboratories, and that may have serious consequences for individual treatment decisions. In parallel, most patients do not have access to expensive gene expression testing for risk prediction of ER+ HER2- breast cancers. By teaming up, Stratipath and Visiopharm can deliver comprehensive digital assessments in early breast cancer.

Bring clarity at first Multidisciplinary Team (MDT) meeting

Together, the solutions create a more actionable first-MDT pathway for early breast cancer: Complete accurate ER/PR, HER2 (including low/ultralow) and Ki-67 scoring, then generate a rapid, affordable risk score – reducing reliance on additional molecular assays with long turnarounds.

  1. Visiopharm’s HER2 algorithm helps avoid unnecessary IHC 2+ reflex ISH/FISH so HER2 is ready on time.
  1. Stratipath Breast, validated in HR+/HER2- cohorts, provides immediate prognostic stratification and reduces the need for costly and time-consuming gene expression tests.
  1. As the therapeutic landscape expands (e.g., HER2-low/ultralow agents and adjuvant CDK4/6 inhibitors where Ki-67 can inform eligibility), a complete biomarker profile plus AI prognostication lets MDTs tailor each patient’s plan without risking delays.

Modern healthcare requires fast and cost-efficient solutions with improved diagnostic accuracy” says Johan Hartman, professor of tumor pathology at Karolinska Institutet and Chief Medical Officer at Stratipath. “Bringing automated biomarker assessment and AI-based prognostication together means more patients can be sub-categorized accurately and on time at the first MDT, supporting confident treatment decisions.”

Delivering Faster, More Accessible Precision Diagnostics

Both Visiopharm’s diagnostic algorithms and Stratipath Breast are regulatory approved medical devices, enabling immediate clinical use. By combining these applications, pathology departments can deliver faster, more precise results – reducing overtreatment, undertreatment, and healthcare costs, while ensuring broader access to precision medicine.

“No single algorithm solves modern pathology; it’s a puzzle of complementary tools. Put the right ones together and 1+1 adds up to more than 2.” says Jeppe Thagaard, Scientific Director at Visiopharm. “Working with partners like Stratipath reflects our principle: measurable patient benefit and a simple, sustainable way for labs to pay for it.”

“As an active pathologist, I focus on ensuring these tools work seamlessly in clinical practice. Stratipath Breast represents the future of prognostic testing, integrated into digital pathology workflows alongside applications for automatic biomarker assessment. Combining them will save time, resources, and ultimately improve patient treatment decisions,” says Johan Hartman , Professor of pathology at Karolinska Insitutet and CMO at Stratipath.

Next Steps

As a first step, Stratipath and Visiopharm will initiate joint case studies at selected hospitals, mapping how the two applications can be combined in daily pathology practice.

The concept will be showcased in more detail at the Visiopharm booth during ECP 2025 in Vienna with results expected to be presented later this year.

Pathology and oncology departments interested in participating in these studies or adopting the combined solution are encouraged to reach out for further discussions.

About Stratipath

Stratipath is an AI company dedicated to revolutionising cancer treatment decisions and enhancing patient outcomes by assisting physicians in delivering optimal treatment to every patient. Stratipath’s pioneering solutions and AI-based precision diagnostic software platform transform tissue sample analysis, enabling breakthrough insights for enhanced and faster patient stratification across healthcare, clinical trials, and drug development. By expanding the reach of precision medicine, Stratipath aims to make this advanced healthcare approach accessible to a wider patient population. Founded as a spin-out of Karolinska Institutet in Stockholm, Sweden, Stratipath is built upon years of groundbreaking research and development. For more information, please visit www.stratipath.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.

Document ID:  17474_09_2025

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