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.