The ArteraAI Prostate Test was included in the NCCN Clinical Practice Guidelines in Oncology for Prostate Cancer, making it the first AI enabled risk stratification tool recommended in those guidelines. It carries a Level 1B evidence rating under Simon Criteria and a Category 2A recommendation. This followed FDA De Novo marketing authorization in August 2025 and CMS coverage effective January 2024.
Our readGuideline inclusion is a different class of validation from a vendor claim or even a regulatory clearance, because an independent panel evaluates the underlying evidence and decides whether clinicians should consider the tool at all. For a center weighing AI diagnostics, this is the clearest available answer to the question of whether a test has been assessed by people with no commercial interest in the answer. The specific standing matters: Level 1B evidence under Simon Criteria and a Category 2A recommendation indicating uniform NCCN consensus that the test is a useful option. Note also what the guideline language constrains, since it positions the test as used in addition to NCCN risk category, patient characteristics, and patient preference, which is an externally imposed limit on how far the output may be relied upon.