Artera Enrolls First Patient in DIRECT-AI Registry, Marking Milestone in Real-World Evidence Generation for AI-Powered Prostate Cancer Care

First nationwide study of its kind will evaluate how the ArteraAI Prostate Test informs treatment decisions in routine clinical practice

SAN FRANCISCO--(BUSINESS WIRE)--Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, today announced the enrollment of the first patient in its DIRECT-AI registry study, marking the beginning of real-world prospective evidence generation for the first nationwide registry evaluating the clinical utility of an AI-powered prostate cancer test. The first patient was enrolled at The Urology Place, a leading independent urology practice in San Antonio, TX, recognized for its commitment to advancing innovation in prostate cancer care.

Building on extensive clinical validation of the ArteraAI Prostate Test, the enrollment of the first patient marks the next phase in evaluating how the test influences treatment discussions, shared decision-making, and long-term outcomes for patients with localized prostate cancer.

The non-interventional observational registry follows patients receiving the ArteraAI Prostate Test as part of their standard care, without requiring additional procedures. Data collected from participating clinical sites across the United States will provide insights into how AI-powered prognostic and predictive information is used in clinical decision-making, including the impact of results on shifts in treatment choices and physician confidence.

“As clinicians, we’re constantly evaluating whether new technologies truly change the way we care for patients or provide meaningful value beyond existing approaches,” said Naveen Kella, M.D., Founder and Director of The Urology Place. “DIRECT-AI allows us to better understand how AI-powered insights are incorporated into routine clinical practice and how they support more informed conversations. We’re proud to contribute to generating this evidence, as it is an important step toward advancing more personalized prostate cancer care.”

Prostate cancer treatment decisions are highly individualized and can depend on multiple factors, including disease characteristics, patient preferences, age, clinical comorbidities, and the potential benefits and risks of different approaches. As treatment options continue to evolve, generating evidence on how new tools perform in real-world settings is essential to understanding their clinical utility. In addition, real-world evidence from DIRECT-AI may help inform subsequent health economic and cost-effectiveness analyses by providing insights into how AI-guided treatment decisions change patterns of care and healthcare resource utilization.

“Clinical validation demonstrates a test’s performance; clinical utility helps us understand its impact in real-world care,” said Calvin Chao, MD, Vice President of Medical Science at Artera. “DIRECT-AI reflects Artera’s commitment to generating evidence that can inform how AI-powered tools are integrated into oncology practice and help shape the future of precision medicine.”

For more information, visit info.artera.ai/directai.

About Artera

Artera is a global leader in precision medicine, leveraging multimodal artificial intelligence (MMAI) to personalize cancer care. Artera’s MMAI platform leverages a patient’s digitized histopathology images along with the patient’s clinical data to determine cancer aggressiveness and predict therapy benefit. This approach has been validated in multiple Phase 3 randomized trials across different cancers and is available in multiple versions across the globe.

Artera’s FDA-authorized software products include ArteraAI Prostate (de novo authorization) and ArteraAI Breast (510(k) clearance). In addition, Artera has received CE Marking for its prostate and breast cancer in vitro diagnostic tests, supporting regulated availability in international markets.

Artera’s flagship product, the ArteraAI Prostate Test, is commercially available as a laboratory-developed test in the US and internationally through its distribution partners. The ArteraAI Prostate Test is the first of its kind to deliver both prognostic and predictive insights for patients with prostate cancer, empowering clinicians and patients to make more informed treatment decisions.

Artera’s headquarters is based in Los Altos, California, while its CLIA-certified and clinical laboratory is located in Jacksonville, Florida. For more information about Artera, visit artera.ai.