Diagnexia, the UK's leading provider of AI-powered digital pathology diagnostic services, has announced an exclusive partnership with Artera to introduce the ArteraAI Prostate Biopsy Assay to the UK market. This collaboration brings the first multimodal AI risk stratification tool for localized prostate cancer patients to British clinicians, representing a significant advancement in personalized cancer treatment.
Revolutionary AI Technology for Prostate Cancer
The ArteraAI Prostate Biopsy Assay represents a breakthrough in prostate cancer diagnostics, combining patient clinical data—including age, PSA levels, and T-stage—with AI interpretation of biopsy slides. This multimodal approach eliminates the need for additional invasive procedures or expensive molecular tests while providing clinicians with actionable insights for treatment planning.
The test is the first AI-enabled diagnostic of its kind to receive recommendation from the National Comprehensive Cancer Network (NCCN) in the USA for localized prostate cancer management.
Clinical Capabilities and Performance
The ArteraAI test offers three key clinical applications: risk assessment that estimates the likelihood of distant metastasis and prostate cancer-specific mortality over 10 years, therapy guidance that predicts the benefit of short-term androgen deprivation therapy (ADT) when combined with radiotherapy, and personalized insights that enhance decision-making for active surveillance and likelihood of future adverse pathology.
Clinical validation data demonstrates the test's superior performance compared to standard risk stratification models. According to data published in Nature, the ArteraAI test showed a 9.2% to 14.6% relative improvement over standard tools at a median follow-up of 11.4 years for prognosticating distant metastasis, biochemical failure, prostate cancer-specific mortality, and overall survival.
The test can identify 34% of patients who may benefit from short-term hormone therapy. In patients who were AI biomarker negative, the test had a hazard ratio of 0.92 (95% CI, 0.59 to 1.43; P = .71; n = 1046) in identifying patients who may not need short-term hormone therapy. For AI biomarker positive patients, the test demonstrated a hazard ratio of 0.34 (95% CI, 0.19 to 0.63; P < .001; n = 673) in identifying who may benefit from short-term hormone therapy.
Real-World Impact Assessment
Artera has launched the DIRECT-AI registry to evaluate the real-world impact of the ArteraAI Prostate Test on treatment decisions for patients with localized prostate cancer. The study will be conducted in two phases, with Phase 1 assessing the impact of test results on clinical decision-making through survey feedback from participating clinicians and patients.
Phase 2 will focus on monitoring long-term outcomes at 2- and 5-year timepoints, including distant metastasis, prostate cancer-specific mortality, overall survival, adverse pathology at radical prostatectomy, and treatments received.
"Harnessing the power of AI, the ArteraAI Prostate Test marks a significant advancement in the personalized treatment of localized prostate cancer," said Tim Showalter, MD, MPH, chief medical officer at Artera. "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."
Addressing Clinical Challenges
The partnership addresses critical challenges in prostate cancer treatment planning, including long wait times for test results, difficulty predicting disease progression, high costs associated with molecular tests, and frequent occurrence of inconclusive molecular test reports due to insufficient tissue quantity or quality.
For patients, the ArteraAI Prostate Biopsy Assay offers a fast, non-invasive, and affordable risk stratification tool. For clinicians, the partnership provides access to an AI tool that integrates seamlessly into existing workflows, offering data-backed insights to guide personalized treatment plans.
Leadership Perspectives
Donal O'Shea, CEO of Diagnexia, emphasized the transformative potential of the partnership: "This partnership highlights the transformative potential of AI in revolutionising personalised cancer care. As the first and only global digital pathology service, Diagnexia has been at the forefront of digital innovation from the start. We see this new wave of digital biomarkers as a pivotal advancement, and by combining our expertise with Artera's innovative technology, we aim to transform digital diagnostics services in the UK and beyond."
Andre Esteva, CEO of Artera, added: "We're proud to join forces with Diagnexia to bring the ArteraAI Prostate Biopsy Assay to the UK. Together, we aim to empower clinicians with a state-of-the-art AI tool that optimises patient outcomes and sets a new benchmark for prostate cancer care."
Expanded Clinical Applications
Recent data presented at the 2025 American Society of Clinical Oncology Annual Meeting demonstrated additional clinical applications for the ArteraAI test. Using data from the STAMPEDE trial, researchers found that the multimodal AI algorithm could accurately identify which patients with high-risk non-metastatic prostate cancer were most likely to benefit from the addition of abiraterone acetate plus prednisone to standard androgen deprivation therapy.
The study showed that continuous MMAI scores were statistically significantly associated with poorer prostate cancer-specific mortality (HR, 1.65; 95% CI, 1.43 to 1.90; P < .001), metastasis-free survival (HR, 1.42; 95% CI, 1.29 to 1.56; P < .001), and distant metastasis (HR, 1.54; 95% CI, 1.36 to 1.74; P < .001) in these patients.
The ArteraAI Prostate Biopsy Assay will soon be available for order through Diagnexia, providing UK clinicians with access to this advanced AI-powered diagnostic tool for prostate cancer risk stratification.
