Aignostics has introduced RUO software that analyzes digital pathology slides to assess tumor content and tissue quality, potentially helping laboratories identify unsuitable samples before molecular testing begins.


Aignostics has introduced HETA Clinical, a new suite of pan-cancer artificial intelligence products designed to assess whole-slide hematoxylin and eosin (H&E) images, accelerate pathology workflows, and decrease failure rates during downstream molecular testing.

Pathology laboratories routinely evaluate slide quality and tissue adequacy by visual inspection—a manual process subject to inter-observer variability. Pathologists at academic medical centers and precision medicine laboratories estimate that 10% to 20% of molecular tests fail because tissue specimens lack sufficient tumor content, often leading to repeat biopsies and prolonged turnaround times. HETA Clinical is designed to help laboratories triage incoming cases, expedite processing, and confirm that tissue samples contain adequate tumor cellularity before molecular analysis begins.

The initial rollout includes four products that quantify slide quality, tumor presence, mitotic counts, and tumor cellularity across whole-slide images.

“HETA Clinical gives labs a faster path through their workflow,” says Dr Rosemarie Krupar, vice president of pathology at Aignostics, in a release. “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.”

Underlying Platform and Lab Integration

The product family is built on HETA, formerly known as Atlas H&E-TME, Aignostics’ foundation platform for spatial H&E tissue analysis. In a recent study, cell classification by HETA matched or exceeded performance benchmarks set by expert pathologists across multiple tumor types. Because the underlying model spans diverse oncology indications, the tools are applicable across various pathology subspecialties beyond common cancers.

Aignostics plans to expand the HETA Clinical line and integrate the applications with digital pathology image management platforms, including Techcyte Fusion AP. The company also recently released early access to PathoSearch, a visual search engine designed to assist pathologists in referencing historical cases.

The HETA Clinical products are currently labeled for research use only and are not for use in diagnostic procedures.

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