AI-Based Assays Support Risk Stratification in Prostate and Breast Cancer

Clinicians increasingly seek objective tools that use routine pathology to anticipate progression risk and identify patients most likely to benefit from adjunctive therapies. A newly CE‑marked pair of artificial intelligence assays now supports personalized risk assessment and treatment decision support for these cancers across Europe.

Artera has obtained CE marking under the European Union In Vitro Diagnostic Regulation (EU IVDR) for its ArteraAI Prostate Biopsy Assay and ArteraAI Breast Cancer Assay. The ArteraAI Prostate Biopsy Assay, the company’s flagship product, is positioned as the first CE-marked AI-enabled prognostic and predictive in vitro diagnostic test for prostate cancer in the European Union. The assay estimates the likelihood of disease progression and mortality risk and assesses whether patients are likely to benefit from adding short-term hormone therapy (ST-ADT) to treatment.

Both assays are built on a multimodal artificial intelligence (MMAI) approach that analyzes digitized histopathology images together with patient clinical variables to characterize tumor aggressiveness and potential treatment benefit. The software is intended for use by pathology laboratories after a cancer diagnosis to provide enhanced risk stratification. It is designed to integrate into existing laboratory workflows without requiring new procedures.

The CE marking enables clinical use in all 27 European Union member states and EFTA countries, including Iceland, Liechtenstein, and Norway, collectively covering a population of around 450 million people. The assays were evaluated for quality, general safety, and performance requirements, with clinical evidence assessed as applicable. These European clearances follow recent U.S. Food and Drug Administration (FDA) De Novo authorization of ArteraAI Prostate, the first AI‑powered software authorized to prognosticate long‑term outcomes in patients with non‑metastatic prostate cancer.

With CE marks in both prostate and breast cancer, Artera positions its platform among the first multicancer AI offerings available in the European Union. The MMAI platform has been clinically validated in global patient cohorts and presented in leading scientific forums, including the San Antonio Breast Cancer Symposium. The company reports ongoing discussions with pathology laboratories and healthcare partners across Europe to establish local access and ordering pathways.

“Achieving CE marking for our prostate and breast cancer tests represents a pivotal milestone for Artera and underscores the scalability of our multimodal AI (MMAI) platform. Validating our AI‑driven approach under one of the world’s most rigorous regulatory frameworks marks an important step in our global deployment and advances our mission to bring AI‑powered decision‑making to precision oncology,” said Andre Esteva, CEO and co‑founder of Artera.

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