Aiforia Gastric Suite

Aiforia® Gastric Suite is a clinical AI solution designed to assist pathologists in the detection of gastric carcinoma and Helicobacter pylori (H. pylori) in digitized whole slide images. Manual screening for these conditions is time-consuming and subject to interobserver variability, particularly when tumor foci are subtle or bacterial density is low. By leveraging AI-driven image analysis, the Gastric Suite highlights suspicious areas directly on the digital slide, enabling efficient review while keeping the pathologist fully in control of interpretation and final reporting.

The suite is built on Aiforia's Foundation Engine technology and is part of the broader Aiforia® Clinical Suites portfolio, which combines results from multiple AI models, whole slide images, and stainings into a unified case-level view and report for first-read diagnostic support.

AI Models Included in the Gastric Suite

• Aiforia® Gastric Cancer: A CE-IVD marked AI solution that assists pathologists in identifying carcinoma areas in digitized H&E-stained gastric tissue samples. It supports diagnostic decision-making while ensuring pathologists can review or modify AI findings before final report approval. It is CE-IVD marked for diagnostic use in EU and EEA countries (IVDR) and available as Research Use Only (RUO) and Performance Studies Only (PSO) in all other market areas.
• Helicobacter pylori (H. pylori) AI Model: Supports identification of H. pylori in gastric tissue samples where bacteria may be sparse, unevenly distributed, or difficult to detect by manual review alone. It highlights areas of interest directly on the whole slide image to guide the pathologist's attention and support efficient verification. Currently available as RUO and PSO in all market areas.

Clinical Performance Highlights

• Designed for high sensitivity, supporting detection of suspicious regions regardless of lesion size or location
• Supports consistent interpretation across different readers, reducing interobserver variability
• Integrates seamlessly into routine digital pathology workflows
• Built to support detection across major histological patterns of gastric carcinoma, including small, scattered, or poorly cohesive tumor cells commonly found in biopsy material

Key Platform Capabilities

• Precise, transparent AI results: Goes beyond standard AI heatmaps by clearly marking exact tumor areas with detailed visual overlays directly on digital slides, enabling easy visual confirmation at any magnification level. Provides quantitative data such as accurate tumor area measurements and cell counts.
• Comprehensive case-level review and reporting: Combines results from multiple AI models, whole slide images, and stainings into a single case-level view and report for streamlined first-read diagnostic support.
• Workflow acceleration: AI results are populated directly into the reporting panel, with advanced features including case list triaging, pre-ordering of extra stains, and flagging of non-representative samples to speed up each step in the workflow.
• Designed for difficult cases: Specifically engineered to address the challenges of detecting gastric cancer presentations that are most likely to be missed in routine practice, such as fragmented, poorly cohesive, or subtly distributed tumor cells.

Aiforia® Gastric Suite is designed for integration into digital pathology environments and is compatible with a range of slide scanners. The solution is intended for use by pathologists in clinical diagnostics (where CE-IVD marked) as well as in research and performance study settings, with regulatory status varying by market area.