Stratipath has announced a strategic integration and distribution partnership with US-based PathAI. The collaboration will make Stratipath Breast, the first CE-IVD marked AI solution for breast cancer prognostic risk profiling, available through PathAI’s AISight Dx Image Management System (IMS).
The company boasts that, unlike traditional gene expression tests, which can be costly, slow, and difficult to access, the artificial intelligence (AI)-powered platform delivers validated prognostic results in under one hour, directly from routine histopathology slides. This rapid turnaround supports clinical decision-making during tumor board reviews, helping oncologists tailor treatments more effectively.
By embedding Stratipath Breast within AISight Dx, pathologists will gain immediate access to actionable risk profiles within their existing diagnostic workflow. The integration eliminates the need for additional equipment or logistics, paving the way for more efficient, equitable, and scalable precision diagnostics.
“We are proud to partner with PathAI to bring Stratipath Breast into the AISight Dx system,” said Fredrik Wetterhall, CEO and Co-founder of Stratipath. “Together, we are scaling access to a transformative solution that delivers rapid and reliable prognostic insights, ensuring every breast cancer patient can receive the right treatment at the right time.”
Regulatory Clearance
PathAI, which recently secured US Food and Drug Administration (FDA) clearance for AISight Dx in primary diagnosis, sees the move as a critical step in strengthening its digital pathology ecosystem.
“Our expanded AI portfolio now including Stratipath Breast brings validated prognostic results directly into the hands of pathologists,” said Andy Beck, MD, PhD, Co-founder and CEO of PathAI. “This accelerates adoption and reinforces trust in digital workflows.”
AISight Dx is a cloud-native platform designed to streamline pathology workflows, offering intelligent case management, high-performance slide review, and real-time collaboration. With FDA clearance and CE-IVD marking across key markets, PathAI’s system is poised to redefine how pathology labs, hospitals, and academic centers deliver timely, high-quality diagnoses.
