CE Mark Approval Granted to Artera’s AI-Based Prostate and Breast Cancer Assays

Artera has won CE marking under the European Union In Vitro Diagnostic Regulation (EU IVDR) for both its ArteraAI Prostate Biopsy Assay and ArteraAI Breast Cancer Assay.

The ArteraAI Prostate Biopsy Assay is the first CE-marked artificial intelligence (AI)-enabled prognostic and predictive in-vitro diagnostic (IVD) test for prostate cancer in the European Union. The test helps predict the likelihood that prostate cancer will spread as well as mortality risk, and helps determine whether a patient is likely to benefit from adding short‑term hormone therapy (ST‑ADT) to his treatment.

This milestone reflects Artera’s continued regulatory momentum, following the recent U.S. Food and Drug Administration (FDA) De Novo authorization of ArteraAI Prostate, the first and only 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 is among the first companies to bring a multicancer AI platform to the European Union, expanding access to AI-driven prognostic and predictive insights for two of the most commonly diagnosed cancers worldwide, according to the company. Both tests use digitized histopathology images and patient clinical variables to determine cancer aggressiveness and potential treatment benefits. These tests allow physicians and patients to better personalize care and achieve better outcomes, avoiding both under- and/or over-treatment. 

The assays were evaluated for quality, general safety, and performance requirements, with clinical evidence assessed as applicable, supporting Artera’s global readiness for commercial deployment across multiple cancer types.

“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,” Artera Co-Founder/CEO Andre Esteva said. “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.”

Artera’s software is intended for use by pathology labs after a cancer diagnosis to provide enhanced risk stratification and can be easily integrated into existing workflows without requiring new procedures. The CE marking enables the clinical use of Artera’s AI-powered tests across all 27 EU member states, in addition to EFTA countries, including Iceland, Liechtenstein, and Norway. This collectively covers a population of around 450 million people. Artera is actively in discussions with pathology laboratories and healthcare partners across Europe to establish local access and ordering pathways. 

The ArteraAI Breast Cancer Assay builds on Artera’s MMAI platform, which has been clinically validated in global patient cohorts and presented in leading scientific forums. 

Artera leverages multimodal artificial intelligence (MMAI) to personalize cancer care. Artera’s MMAI platform leverages a patient’s digitized histopathology images and clinical data to determine cancer aggressiveness and predict therapy benefit. This approach has been validated in multiple Phase 3 randomized trials across different cancers and is available in multiple versions globally.

Artera’s flagship product, the ArteraAI Prostate Test, is the first of its kind to deliver both prognostic and predictive insights for patients with prostate cancer, empowering clinicians and patients to make more informed treatment decisions. Additional MMAI-powered products include the ArteraAI Breast Cancer Assay (UKCA and CE Mark approval), the ArteraAI Prostate Biopsy Assay (UKCA and CE Mark approval), and ArteraAI Prostate (FDA approval). Artera has regulatory authorization for its medical device product in the United States, United Kingdom, and EU.

Artera is based in Los Altos, Calif., while its CLIA-certified and clinical laboratory is located in Jacksonville, Fla.