The regulatory milestone allows for the clinical use of the prognostic and predictive assays across the European Union and additional territories.
Artera, a developer of multimodal AI-based prognostic and predictive cancer tests, announced it has received CE marking under the European Union In Vitro Diagnostic Regulation for the ArteraAI Prostate Biopsy Assay and the ArteraAI Breast Cancer Assay.
The ArteraAI Prostate Biopsy Assay is the first CE-marked AI-enabled prognostic and predictive in vitro diagnostic test for prostate cancer in the European Union, according to the company. The test is designed to help predict the likelihood of prostate cancer metastasis, the risk of mortality, and whether a patient is likely to benefit from the addition of short-term hormone therapy to their treatment.
This regulatory milestone follows a recent t Food and Drug Administration De Novo authorization in the US for ArteraAI Prostate. That software is intended to prognosticate long-term outcomes in patients with non-metastatic prostate cancer, the company says.
Multimodal AI Platform Expansion
With the new CE marks, Artera is among the first companies to offer a multicancer AI platform in the EU. Both tests utilize digitized histopathology images and patient clinical variables to determine cancer aggressiveness and potential treatment benefits. According to the company, these tests allow physicians and patients to personalize care and achieve better outcomes while avoiding under-treatment or over-treatment.
“Achieving CE marking for our prostate and breast cancer tests represents a pivotal milestone for Artera and underscores the scalability of our multimodal AI platform,” says Andre Esteva, chief executive officer and co-founder of Artera, in a release. “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.”
The assays were evaluated for quality, general safety, and performance requirements, with clinical evidence assessed to support global commercial deployment across multiple cancer types, the company says.
Integration into Pathology Workflows
Artera’s software is intended for use by pathology laboratories after a cancer diagnosis to provide risk stratification. The software can be integrated into existing workflows without requiring new clinical procedures, according to the release.
The CE marking enables clinical use of the tests across all 27 EU member states, as well as European Free Trade Association countries, including Iceland, Liechtenstein, and Norway. This expansion covers a population of approximately 450 million people. Artera is currently in discussions with pathology laboratories and healthcare partners across Europe to establish local access and ordering pathways, the company says.
The ArteraAI Breast Cancer Assay is built on the company’s multimodal AI platform, which has been clinically validated in global patient cohorts and presented at the San Antonio Breast Cancer Symposium, according to the release.
