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Aignostics Unveils HETA Clinical: Transforming Pathology with AI

In a remarkable development for the field of medical diagnostics, Aignostics has announced the launch of HETA Clinical, a pioneering range of artificial intelligence (AI) products designed to optimize pathology workflows and reduce the failure rates of molecular tests related to cancer diagnosis. This new offering, which covers the entire pathological workflow from sample reception and evaluation to molecular testing, is set to make a significant impact on the efficiency and accuracy of cancer diagnostics.

What is HETA Clinical?

HETA Clinical comprises four initial products that focus on critical aspects of sample quality assessment and tumor detection. The primary features include:

1. Quality Control of Samples: This product evaluates the condition of tissue samples before analysis, identifying potential issues that could affect test outcomes.
2. Tumor Detection: Utilizing advanced algorithms, this tool marks tumor regions and prioritizes cases with a higher probability of tumor presence during scanning, ensuring that these cases receive immediate analysis and necessary additional staining upon receipt.
3. Mitosis Counting: This feature provides reliable mitotic counts, thereby facilitating reproducibility across tests, which is crucial for accurate diagnostics.
4. Tumor Cellularity Assessment: HETA evaluates the cellular content of tumors and recommends regions with sufficient tumor presence for further molecular analysis.

Traditionally, these evaluations are performed visually, a process fraught with subjectivity and time-consumption. Many pathologists estimate that between 10% to 20% of molecular tests fail due to insufficient tumor presence in the tissue, leading to repeated biopsies and delays in results. HETA Clinical aims to address these challenges by enabling laboratories to prioritize cases, streamline response times, and ascertain the adequacy of tumor content before molecular testing takes place.

Expert Insights

Dr. Rosemarie Krupar, Vice President of Pathology at Aignostics, stated, "HETA Clinical provides laboratories with a faster pathway in their workflows. Measurements such as tumor content and mitotic count are fundamental to many pathology specialties, significantly influencing the downstream work associated with a sample. Cell-by-cell quantification is an area where AI provides large-scale consistency, freeing up pathologists to focus on elements of the job that require their expertise."

The underlying technology for HETA Clinical is based on HETA (formerly known as Atlas HE-TME), Aignostics' core platform for spatial tissue analysis using hematoxylin and eosin (HE) staining. Recent studies indicate that cellular classifications made by HETA match or even exceed those made by expert pathologists. The comprehensive nature of HETA allows the new clinical products to cater to a wide range of cancer types, extending AI applications to various pathology subspecialties beyond just common cancers.

Expansion into the Pathology Space

Aignostics has also announced the early access launch of PathoSearch, a visual search engine designed for pathology cases. Additionally, there are plans for more products under the HETA Clinical umbrella to be integrated with image management systems, including Techcyte Fusion® AP. Pathologists utilizing Fusion can reach out to their Techcyte representative to request demonstrations of the product.

For researchers, sample testing using HETA Clinical is currently for research purposes only and is not approved for diagnostic procedures.

About Aignostics

Founded in 2020 and stemming from Charité Berlin—one of the world's largest and most prestigious university hospitals—Aignostics leverages AI technology to provide validated tissue analysis supported by clinical research. By marrying exclusive access to multimodal clinical data with industry-leading technology and rigorous science, Aignostics develops pioneering products aimed at ushering in the next generation of precision medicine. The company is backed by prominent investors like the Mayo Clinic and operates out of Berlin and New York.

For more information, visit Aignostics Website and follow them on LinkedIn. For media inquiries, contact Lisa Zheng at [email protected].