Berlin's Aignostics launches four AI pathology tools to cut failed molecular tests

Aignostics, the Berlin pathology AI company spun out of Charité, launched HETA Clinical on 16 October 2026: a set of four AI tools that score whole slide H&E images for slide quality, tumour presence, mitotic count and tumour cellularity ¹. The company is selling them for research use only, not for diagnostic procedures ¹.

What the products do

Each tool takes on a measurement that pathologists normally make by eye ¹. HETA Quality Control checks a slide for quality problems before it is analysed. HETA Tumor Detect marks tumour regions and flags likely tumour cases at the point of scanning, so they can be read first and extra stains ordered at intake. HETA Mitosis produces a mitotic count. HETA Tumor Cellularity measures how much of the tissue is tumour and proposes a region with enough tumour to send for molecular testing ¹.

The last of these is where Aignostics makes its main commercial argument. Pathologists the company spoke to at academic medical centres and precision medicine labs estimate that 10 to 20 percent of molecular tests fail because the tissue lacks enough tumour, which can mean repeat biopsies and long delays ¹. That figure is an estimate gathered by the company, not a measured result from a study ¹.

All four products sit on HETA, previously called Atlas H&E-TME, the company's pan-cancer platform for spatial analysis of H&E tissue ¹. Aignostics says that in a recent study HETA's cell classification matched or exceeded that of expert pathologists, and that because the platform covers a broad range of cancers the tools reach subspecialties beyond the most common tumour types ¹. Dr Rosemarie Krupar, Aignostics' vice president of pathology, said cell-by-cell quantification "is where AI delivers consistency at scale" ¹.

What it means for the market

For laboratory and pathology leaders, the launch adds a European supplier to the market for AI that sits inside the routine slide workflow rather than at the point of diagnosis. The four tools target triage, quality and sample adequacy, which are steps that set turnaround times and decide whether an expensive molecular test is worth running ¹. Aignostics plans to release more HETA Clinical products over time and to integrate them with image management systems, starting with Techcyte Fusion AP ¹. Integration matters to buyers because tools of this kind are only usable at scale when they run inside the system pathologists already read slides in.

The company also serves biopharma R&D alongside clinical labs, counts Mayo Clinic among its investors and operates in Berlin and New York ¹. It recently opened early access to PathoSearch, a visual search engine for pathology cases ¹.

What is not yet known is how fast any of this can reach routine clinical use. The release names no customers, no prices and no regulatory marking, and gives no timetable for diagnostic use ¹.

Limits

The evidence offered is the company's own: an unnamed recent study on cell classification and a failure rate estimated from conversations with pathologists ¹. The research-use-only label means the tools cannot be used to make diagnostic decisions in their current form ¹.