Artera has been 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, according to an announcement.
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 follows 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.
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.
More information about how AI and computational pathology unlock valuable data from routine slides, enabling personalized, patient-centered treatment decisions can be found in this MLO Online Exclusive article written by Artera’s CMO here.
Read Artera's announcement on Businesswire
