Swedish AI Precision Pathology 2
About
SwAIPP2 (Swedish AI Precision Pathology 2) is a national cross-sector innovation environment funded by Vinnova (Sweden's innovation agency) and coordinated by Karolinska Institutet. Its mission is to develop, translate, and implement AI-based precision diagnostics in pathology - making faster, more accurate, and more cost-effective cancer diagnostics available to patients in Sweden and beyond.
The programme builds on the success of its first phase (2021-2024), in which SwAIPP supported intial translation and clinical implementation of Stratipath Breast - the first CE-IVD marked AI solution for prognostic risk stratification of breast cancer based on routine histopathology whole slide images (WSIs). In its second phase (2024-2027), SwAIPP2 expand the programme by adding new partners, new diagnostic applications, and on regulatory compliance (CE-IVDR), cybersecurity, and international reach.
At the core of SwAIPP2 approach is AI-based analysis of digitised histopathology slides - an approach that enable extraction of prognostic and predictive information comparable to expensive molecular assays, but at a fraction of the cost and turnaround time. With all Swedish pathology laboratories now digitised, the infrastructure is in place to deploy these solutions at scale. Breast cancer remains the primary focus in SwAIPP2.
Overview of SwAIPP2 objectives
- Develop and clinically implement 1-2 additional AI-based precision diagnostic solutions for breast cancer, building on the established regulatory pathway and translational model from SwAIPP's first phase.
- Advance regulatory compliance and cybersecurity by achieving CE-IVDR certification for current and new AI medical devices, implementing a compliant quality management system (QMS), and meeting cybersecurity standards.
- Scale clinical deployment to at least three additional Swedish healthcare regions, conducting real-world testing and evaluation to establish the performance, usability, and health economic value of AI-based precision pathology in routine care.
- Build an internationally competitive innovation environment that bridges academic research, regulated medical device development, and clinical implementation.
- Ensure equitable and sustainable access to precision diagnostics by providing AI-based alternatives to costly molecular assays, reducing time-to-diagnosis, and enabling high-quality cancer diagnostics regardless of a patient's geographical location or the local level of pathology expertise.
Partners
SwAIPP2 brings together ten partners spanning academic research, clinical healthcare, medical device development, digital pathology infrastructure, regulatory compliance, cybersecurity, and patient advocacy - covering all steps from research to clinical implementation
Karolinska Institutet (KI)
One of the world's leading medical universities and the coordinating hub of SwAIPP². Two research groups drive the scientific core: the Predictive Medicine group (Rantalainen) specialising in AI and large-scale computational pathology, and the Molecular and Precision Pathology group (Hartman) leading clinical histopathology research.
Stratipath AB
Stratipath developed Stratipath Breast — the first CE-IVD marked AI solution for prognostic risk stratification of breast cancer from routine histopathology slides — now in clinical use at multiple Swedish hospitals.
Proscia
A US-based digital pathology software company and provider of the Concentriq® enterprise pathology platform. In SwAIPP², Proscia contributes IT infrastructure and image management system integration.
Prevas AB
A Swedish engineering consultancy with deep expertise in regulatory and quality compliance for medical devices and in vitro diagnostics (IVD). Prevas supports SwAIPP² in navigating the CE-IVDR regulatory pathways.
Certezza AB
Certezza AB
An independent Swedish information and cybersecurity company founded in 1996. Certezza leads the cybersecurity workstream in SwAIPP², conducting security assessments and supporting compliance
Region Uppsala
A leading Swedish healthcare region, home to Uppsala University Hospital, with an accredited digital pathology laboratory diagnosing over 350 breast cancers annually. Region Uppsala participates in clinical validation studies and real-world deployment of AI-based diagnostic solutions.
Västra Götalandsregionen
One of Sweden's largest healthcare regions, with an accredited digital pathology laboratory at Sahlgrenska University Hospital diagnosing over 1,700 breast cancers per year. Region Västragötaland provides a high-throughput clinical environment for validation studies and large-scale real-world implementation of AI solutions in SwAIPP².
Region Västerbotten
A northern Swedish healthcare region with an accredited digital pathology laboratory diagnosing over 250 breast cancers annually. Region Västerbotten's involvement ensures geographic diversity in validation cohorts and demonstrates that AI-based precision diagnostics can be implemented across regions with varying patient volumes.
Bröstcancerförbundet (Swedish Breast Cancer Association)
Sweden's only patient advocacy organisation dedicated exclusively to breast cancer, with nearly 12,000 members and 34 local associations nationwide. In SwAIPP², Bröstcancerförbundet serves as a patient reference group, providing the patient perspective on diagnostics, quality of life, and privacy, and plays a key role in communicating results to patients and the wider public.
SwAIPP2 is funded by Vinnova (Swedish Innovation Agency) and coordinated by Karolinska Institutet, 2024 - 2027
