Artera Launches Registry Trial to Measure Real-World Impact and Outcomes of its Prostate Test

Data from Artera’s DIRECT-AI registry will assess the test’s impact on cancer care and guide future improvements

Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced the launch of its DIRECT-AI registry study. This study will assess how the ArteraAI Prostate Test influences treatment decision-making between clinicians and patients with localized prostate cancer. Additionally, the study will monitor participants to evaluate their long-term cancer outcomes, reinforcing Artera's commitment to advancing personalized cancer treatment and identifying future opportunities for test optimization.

The DIRECT-AI study centers on the award-winning ArteraAI Prostate Test—the only test included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for localized prostate cancer that can both predict therapy benefit and prognosticate long-term outcomes.

"Harnessing the power of AI, the ArteraAI Prostate Test marks a significant advancement in the personalized treatment of localized prostate cancer. Through the DIRECT-AI registry, we are rigorously evaluating how this technology can enhance clinical decision-making and improve patient outcomes, providing clinicians and patients with the most accurate, tailored insights available," said Dr. Tim Showalter, Chief Medical Officer at Artera.

The study is structured into two phases. The initial phase captures real-world insights into how the Artera Prostate Test informs clinical decision-making, with feedback collected from participating clinicians and patients. The second phase will monitor long-term health outcomes at key intervals of 2 and 5 years, looking at endpoints such as distant metastasis, survival rates, and treatment effectiveness. This research will help Artera understand how its test impacts cancer outcomes and monitor its performance so that it can be improved for patients in the future.

Any patient receiving the commercial ArteraAI Prostate Test and whose ordering physician is associated with an enrolling clinic is eligible to participate in the study. Patients must have localized prostate cancer and must not have started or received treatment for their condition. The study is non-interventional, meaning it does not require additional procedures or tests, and there will be no changes to the care participants receive, regardless of their participation.

For clinics participating in the DIRECT-AI Registry, physicians can enroll all patients for whom they order an ArteraAI Prostate Test in the study.

For more information and to sign up, visit the website or contact direct-ai@artera.ai.

About Artera

Artera is a leading precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer: ArteraAI Prostate Test.

Artera’s multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses digital images from a patient’s biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular therapy and has been validated using many Phase 3 randomized trials.

Artera’s laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera’s laboratory in Jacksonville, Florida, and can be ordered online at Artera.ai.

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