July 2025 Digital Pathology Roundup

Here is the July 2025 Digital Pathology Roundup with Imogen Fitt of Signify Research. Partnerships: Owkin launched a 5-year partnership with Newcastle Upon Tyne Hospitals NHS Foundation Trust to apply agentic AI across drug discovery, development, and diagnostics. First up: an AI tool to screen for gBRCA mutations in breast cancer, with Newcastle running validation studies and contributing multimodal data via Owkin’s ATLANTIS network (20 institutions across 7 countries, 11 therapeutic areas. Lunit teamed with Microsoft to broaden access to cancer-detection AI through Azure-based model fine-tuning and agentic workflow tools; this follows Lunit’s growing DP footprint (e.g., SCOPE PD-L1 TPS integrating with Roche’s platform). AIVIS and AstraZeneca Korea signed an MoU to build an AI-driven HER2 diagnosis ecosystem, clinically implementing AIVIS’ Qanti IHC under the newer, more granular HER2 classification. Regulatory Milestones: Artera received FDA Breakthrough Device Designation (BDD) for ArteraAI Prostate, the first AI risk-stratification tool in prostate cancer predicting metastasis risk and disease-specific mortality from WSIs. CDx Diagnostics also earned BDD for WATS3D, which uses AI on 3D digital pathology images obtained via a proprietary brush for Barrett’s esophagus, dysplasia, and esophageal cancer—run in CDx’s CLIA/CAP/NYS-licensed lab. Other 2025 BDDs include Paige (PanCancer Detect), Roche (VENTANA TROP2 RxDx), and Modella AI (gen-AI co-pilot). Reminder: BDD is not clearance; historically only ~10% progress to full FDA clearance. AI Developments: Google Research/DeepMind expanded MedGemma with MedGemma-27B Multimodal (including EHR interpretation) and MedSigLIP (lightweight image–text encoder) spanning radiology, dermatology, digital pathology, ophthalmology; MedGemma integrates FHIR and medical text. A joint study showed illumiSonics’ MLI can generate virtual H&E-like images from unstained skin tissue that Modella AI’s PathChat DX (without prior virtual-histology training) could analyze with high concordance versus eight dermatopathologists reviewing virtual and matched chemical H&Es—signaling growing momentum for stain-free imaging. Funding: Imagene raised a $23M Series B led by Larry Ellison and Oracle. Scopio Labs unveiled its Complete Blood Morphology analyzer to automate peripheral smear review and analyze ~10× more cells than current practice; Viola Growth added $10M to Scopio’s Series D. Earlier in July, Scopio gained FDA clearance for a Decision Support System on X100/X100HT and a Peripheral Blood Smear app with AI-driven RBC morphology grading.