Artera has secured CE marking under the European Union In Vitro Diagnostic Regulation (EU IVDR) for its ArteraAI prostate biopsy and breast cancer assays, expanding the company’s global reach.
The ArteraAI prostate biopsy assay is said to be the first AI-enabled prognostic and predictive in vitro diagnostic test for prostate cancer granted the CE mark.
It predicts the risk of prostate cancer progression, associated mortality, and assesses if patients could benefit from the addition of short-term hormone therapy (ST ADT) to their treatment plan.
The development follows Artera's receipt of US Food and Drug Administration (FDA) de novo authorisation for its ArteraAI prostate biopsy assay, marking the first AI-powered software cleared for predicting long-term outcomes in non-metastatic prostate cancer patients.
Both tests use digitised histopathology images and clinical variables for determining cancer aggressiveness and possible treatment responses, supporting more customised care.
They underwent evaluation for quality, general safety, and performance, including a comprehensive clinical evidence review. This supports Artera’s readiness to deploy its products commercially on a global scale across various cancer indications.
Artera CEO and co-founder Andre Esteva said: “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.”
The CE marking authorises clinical use throughout all EU member states and EFTA [European Free Trade Association] countries, collectively serving 450 million people. Artera is engaging with European pathology labs and healthcare partners for local access and ordering.
The ArteraAI breast cancer assay leverages Artera’s MMAI platform, clinically validated in global cohorts and presented at scientific events including the San Antonio Breast Cancer Symposium.
