The FDA’s De Novo authorization for the tool establishes a new product code category for future AI-powered digital pathology risk-stratification tools.
The US FDA has granted De Novo marketing authorization for ArteraAI Prostate , a novel artificial intelligence -powered risk-stratification tool for patients with nonmetastatic prostate cancer .provides a marketing pathway to classify low- or moderate-risk novel medical devices.
The De Novo authorization for this specific test establishes a new product code category for future AI-powered digital pathology risk-stratification tools and enables implementation at the point of diagnosis at qualified US pathology labs, the company said. The test analyzes digital pathology images from patients’ biopsy slides to predict long-term outcomes, such as 10-year risk of metastasis and mortality. This can help direct treatment decisions. “Notably, the FDA authorization includes a Predetermined Change Control Plan, granting Artera the ability to expand platform capabilities through validating compatibility with additional digital pathology scanners without requiring further submissions,” according to Artera, which develops multimodal artificial intelligence-based prognostic and predictive cancer tests for personalized cancer care. The STAMPEDE trial helped to establish abiraterone, an androgen receptor pathway inhibitor, along with radiation and long-term androgen deprivation therapy, as the standard of care treatment for high-risk patients. The validation data presented at ASCO demonstrated the test’s ability to differentiate high-risk nonmetastatic prostate cancer patients most likely to benefit from abiraterone from those unlikely to benefit. “For lower-risk patients, the test can help determine if active surveillance is a suitable option, and for intermediate-risk patients, the test can predict if short-term androgen deprivation therapy is beneficial,“Abiraterone has already hugely improved the outlook for hundreds of thousands of men with advanced prostate cancer,” said Nick James, MD, PhD, the lead investigator for STAMPEDE. “We’re excited to now have a test that can pick out the people who will respond best to abiraterone, and those who will do well with standard treatment alone.”The NCCN Guideline states that use of the tool for risk stratification of localized prostate cancer in clinical practice is supported by solid evidence. The Category 2A recommendation signifies uniform NCCN consensus that the tool is appropriate for patients with prostate cancer. “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, a radiation oncologist, cancer researcher, and 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.” Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached atComments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our
Malignant Prostate Neoplasm Prostate Cancer Cancer Of The Prostate Metastatic And Advanced Prostate Cancer Metastatic Prostate Cancer Advanced Prostate Cancer Cancer Malignant Neoplasia Carcinoma Malignant Neoplasm Prostatic Cancer Risk Artificial Intelligence Deep Learning AI NPL Machine Learning ML Natural Language Processing Artificial Neural Networks
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