AI Pathology Platform Targets Workflow Delays and Molecular Test Failures

These tasks can be time-consuming and vary between readers, while insufficient tumor content can cause molecular tests to fail. To streamline these assessments, a newly launched artificial intelligence product family analyzes hematoxylin and eosin (H&E) whole-slide images, helping laboratories prioritize cases and evaluate sample suitability before molecular testing.

Aignostics (Berlin, Germany) has launched HETA Clinical, a pan-cancer family of artificial intelligence (AI) products designed to support pathology workflows from intake and evaluation through preparation for molecular testing. The initial portfolio includes HETA Quality Control, HETA Tumor Detect, HETA Mitosis, and HETA Tumor Cellularity. Together, these tools assess slide quality, tumor presence, mitotic counts, and tumor cellularity across hematoxylin and eosin (H&E) whole-slide images.

HETA Quality Control identifies slide quality issues before analysis, while HETA Tumor Detect annotates tumor regions and flags slides likely to contain tumor during scanning. These flags can help prioritize cases for review and support ordering additional stains at intake. HETA Mitosis provides a reproducible mitotic count, and HETA Tumor Cellularity measures tumor cell content and proposes a region containing sufficient tumor for molecular testing.

All four products build on HETA, formerly Atlas H&E-TME, Aignostics’ core pan-cancer platform for spatial H&E tissue analysis. In a recent study cited by the company, HETA’s cell classification performance matched or exceeded that of expert pathologists. The focus on tumor cellularity also addresses a practical laboratory challenge: pathologists at leading academic medical centers and precision medicine laboratories estimated that 10% to 20% of molecular tests fail because tissue contains insufficient tumor, potentially requiring repeat biopsies and causing lengthy delays.

The products are for research use only and are not for use in diagnostic procedures. Aignostics plans to expand the HETA Clinical product family over time and integrate the products with image management systems, including Techcyte Fusion AP.

“HETA Clinical gives labs a faster path through their workflow. Measurements like tumor content and mitotic count are central to many pathology specialties and shape much of the work that follows a slide. Quantifying them cell by cell is where AI delivers consistency at scale, freeing pathologists' time for the parts of the work that need their expertise,” said Dr. Rosemarie Krupar, VP of Pathology at Aignostics.

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