Artera Secures CE Marking for Its AI Prostate and Breast Cancer Assays, Unlocking Global Expansion

Dual regulatory milestones establish Artera as a global AI leader in precision oncology

SAN FRANCISCO--(BUSINESS WIRE)--Artera, a developer of multimodal AI-based prognostic and predictive cancer tests, announced today that it was granted CE marking under the European Union In Vitro Diagnostic Regulation (EU IVDR) for both its ArteraAI Prostate Biopsy Assay and ArteraAI Breast Cancer Assay, marking a major step in the company’s global expansion.

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

This milestone reflects Artera’s continued regulatory momentum, following the recent FDA De Novo authorization in the U.S. 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 EU, expanding access to AI-driven prognostic and predictive insights for two of the most commonly diagnosed cancers worldwide. Both tests leverage the use of 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- 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,” said Andre Esteva, CEO and co-founder of Artera. “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 cancer diagnosis to provide enhanced risk stratification and can be easily integrated into existing workflows without requiring new procedures. The CE marking enables 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, including the recently held San Antonio Breast Cancer Symposium (SABCS).

Those interested in offering Artera’s CE‑marked tests can register their interest by visiting Artera.ai.

About Artera

Artera is a global leader in precision medicine, leveraging multimodal artificial intelligence (MMAI) to personalize cancer care. Artera’s MMAI platform leverages a patient’s digitized histopathology images along with the patient’s 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 across the globe.

Artera’s flagship product, the ArteraAI Prostate Test, is commercially available as a laboratory-developed test in the US and internationally through its distribution partners. 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-marked), the ArteraAI Prostate Biopsy Assay (UKCA and CE-marked), and ArteraAI Prostate (FDA). Artera has regulatory authorization for its medical device product in the US, UK, and EU.

Artera’s headquarters is based in Los Altos, California, while its CLIA-certified and clinical laboratory is located in Jacksonville, Florida. For more information about Artera, visit artera.ai.