FDA grants de novo authorization to ArteraAI Prostate

The FDA has granted de novo authorization to ArteraAI Prostate, an artificial intelligence (AI)-powered risk stratification tool for patients with non-metastatic prostate cancer, Artera announced in a news release.¹

The tool, which uses multimodal artificial intelligence (MMAI) technology, is now the first and only AI-powered tool to be authorized to prognosticate long-term outcomes in patients with localized prostate cancer.

According to Artera, “The technology’s De Novo authorization establishes a new product code category for future AI-powered digital pathology risk-stratification tools and enables its implementation at the point of diagnosis at qualified pathology labs in the US.” The authorization also includes a Predetermined Change Control Plan, which allows Artera “to expand platform capabilities through validating compatibility with additional digital pathology scanners without requiring further 510(k) submissions.”

“This is a defining moment for AI in cancer care,” said Andre Esteva, CEO and co-founder of Artera, in the news release.¹ “The FDA's decision validates the power of our MMAI platform to deliver on our vision to create AI-guided tools that enable data-backed and tailored treatments for each patient, leading to more confidence throughout the cancer journey, and ultimately, save more lives.”

The ArteraAI test works by analyzing digital images from a patient’s biopsy plus their clinical data to prognosticate outcomes such as 10-year risk of distant metastasis and prostate cancer-specific mortality (PCSM). The tool was previously granted a breakthrough device designation by the FDA in July 2025. Artera noted that the breakthrough device designation specifically pertains to the ArteraAI Prostate medical device, and that the company’s MMAI technology platform is currently available for commercial test ordering via the ArteraAI Prostate Test.

Data on ArteraAI

The ArteraAI Prostate test has been validated using data from several phase 3 trials to predict therapy benefit and prognosticate long-term outcomes.

According to Artera, the ArteraAI test can identify the 34% of patients who may benefit from short-term hormone therapy.² In patients who were AI biomarker negative, the ArteraAI test had an HR 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. In patients who were AI biomarker positive, the test demonstrated an HR of 0.34 (95% CI, 0.19 to 0.63; P < .001; n = 673) in identifying who may benefit from short-term hormone therapy.

The test also demonstrated superiority vs the National Comprehensive Cancer Network risk stratification models in prognosticating for distant metastasis, biochemical failure, PCSM, and OS. According to data published in Nature, the ArteraAI test demonstrated a 9.2% to 14.6% relative improvement over standard tools across all end points at a median follow-up of 11.4 years.³

Additional data on the ArteraAI Prostate Test were presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois.⁵ Using data from the STAMPEDE trial (NCT00268476), investigators found that the MMAI algorithm could accurately identify which patients with high-risk non-metastatic prostate cancer were most likely to benefit from the addition of abiraterone acetate (Zytiga) plus prednisone ± enzalutamide (Xtandi) (ARPI) to standard of care (SOC) androgen deprivation therapy.

Data showed that patients who were biomarkers positive who received treatment with ARPI demonstrated improved PCSM (HR, 0.42; 95% CI, 0.24 to 0.74; P = .003), while patients who were biomarker negative did not show a treatment benefit (HR, 0.85; 95% CI, 0.56 to 1.29; P = .45). The 5-year PCSM was 9% for biomarker positive patients who received ARPI vs 17% among patients who received SOC; these rates were 4% and 7%, respectively, among patients who were biomarker-negative.

“Abiraterone has already hugely improved the outlook for hundreds of thousands of men with advanced prostate cancer,” said Nick James, MD, PhD, lead investigator of the STAMPEDE trial. “We know that for many men with cancer that has not yet spread, it can also have spectacular results. 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 from standard treatment alone—hormone therapy and radiotherapy.”

REFERENCES

1. Artera receives U.S. FDA De Novo Marketing Authorization for AI-digital pathology software revolutionizing prostate cancer care. News release. Artera. August 13, 2025. Accessed August 13, 2025. https://www.businesswire.com/news/home/20250813857439/en/Artera-Receives-U.S.-FDA-De-Novo-Marketing-Authorization-for-AI-Digital-Pathology-Software-Revolutionizing-Prostate-Cancer-Care

2. ArteraAI Prostate Test. Artera. Accessed August 13, 2025. https://artera.ai/arteraai-prostate-cancer-test

3. Esteva A, Feng J, van der Wal D, et al. Prostate cancer therapy personalization via multi-modal deep learning on randomized phase III clinical trials. NPJ Digit Med. 2022;5(1):71. doi:10.1038/s41746-022-00613-w

4. Parker C, Liu V, Mendes L, et al. Multimodal artificial intelligence (MMAI) model to identify benefit from 2nd-generation androgen receptor pathway inhibitors (ARPI) in high-risk non-metastatic prostate cancer patients from STAMPEDE. J Clin Oncol. 2025;43(suppl 16). doi:10.1200/JCO.2025.43.16_suppl.5001