Aignostics launches four AI pathology tools, limited to research use

Aignostics launched HETA Clinical on October 16, 2026, offering four AI tools to check pathology slides and measure tumor characteristics before molecular testing. The company wants laboratories to spot unsuitable samples earlier and prioritize incoming cases. Despite the product family’s name, all four tools are for research use only—not for diagnostic procedures.

Four measurements from a pathology slide

The products analyze whole-slide hematoxylin and eosin images, usually shortened to H&E. Rather than offering one general assessment, the initial lineup separates the work into four tasks: checking image quality, locating tumor, counting mitoses and measuring tumor-cell content. Each output addresses a different point between receiving a slide and selecting tissue for molecular analysis.

• HETA Quality Control checks slide quality before analysis and identifies quality problems. Its place is at the beginning of the workflow: assessing the slide before the laboratory proceeds with the image analysis that follows.
• HETA Tumor Detect marks tumor regions and flags cases likely to contain tumor as slides are scanned. Aignostics says this can help laboratories put those cases first in the reading queue and order additional stains at intake.
• HETA Mitosis counts mitoses. The company describes its output as a reproducible count, targeting a measurement that pathologists would otherwise make by eye. That consistency is a company claim, rather than a quantified result disclosed for this product at launch.
• HETA Tumor Cellularity measures tumor-cell content and proposes a region with enough tumor for molecular testing. The intended output goes beyond identifying tumor somewhere on the slide: it suggests which region has sufficient content for the subsequent analysis.

Aignostics says these assessments are usually visual judgments, which take time and vary between readers. Its pitch is to turn them into measurements that laboratories can use throughout the workflow, while reserving pathologists’ attention for work requiring their expertise.

Measurements like tumor content and mitotic count are central to many pathology specialties and shape much of the work that follows a slide.

Dr. Rosemarie Krupar, vice president of pathology at Aignostics

The failed-test estimate behind the pitch

The tumor-content tool addresses a specific problem: a specimen can reach molecular testing without enough tumor to analyze. Pathologists consulted by Aignostics at academic medical centers and precision-medicine laboratories estimated that this causes 10% to 20% of molecular tests to fail. The company says those failures can mean repeat biopsies and lengthy delays.

That figure describes the problem the company hopes to address; it is not a measured reduction achieved by HETA Clinical. The launch announcement provides no before-and-after molecular-test failure rate for laboratories using the products. Faster processing and fewer failed tests remain intended benefits, not demonstrated outcomes of this release.

A shared platform, with integrations planned

All four applications are built on HETA, Aignostics’ tissue-analysis platform, formerly called Atlas H&E-TME. The company says that platform covers a broad range of cancer types, giving the product family a remit across pathology specialties rather than limiting it to the most common cancers.

Aignostics plans to add more HETA Clinical products and integrate them with image-management systems, including Techcyte Fusion AP. Those are future rollout plans. For now, the company is inviting demo requests and directing pathologists using Fusion to their Techcyte contacts. The research-use restriction remains an important boundary on how the newly launched tools may be used.