Artera, a cancer diagnostics company based in Los Altos, California, has introduced the first artificial intelligence (AI) test designed to help patients choose between active surveillance and treatment for prostate cancer. The test analyzes digital pathology images to guide decision-making.
According to Trevor Royce, MD, MPH, Senior Medical Director at Artera and faculty member in radiation oncology at Wake Forest University School of Medicine, the latest version of the ArteraAI Prostate Test is aimed at patients with low-risk (Grade Group 1/Gleason 6) and favorable intermediate-risk (Grade Group 2/Gleason 3+4) prostate cancer. It helps estimate the likelihood of cancer progression and the potential benefit of treatment for localized prostate cancer.
Royce noted that the test has been validated across a wide range of patients, including those who opted for active surveillance, radiation therapy, or radical prostatectomy. “The test provides a prognostic risk result that reflects the patient’s outlook, regardless of the treatment path chosen,” he said.
The AI test predicts the risk of developing distant metastasis within 10 years and, for patients considering active surveillance, assesses the likelihood of the cancer becoming more aggressive. However, Royce emphasized that the test does not make clinical recommendations. “The decision is ultimately personal and should be made between the patient and their physician, with the test serving as a support tool,” he added.
Currently available in all U.S. states except New York and California—where regulatory approval is pending—the test is priced at $700 for Medicare patients, with no out-of-pocket expenses. Artera is in discussions with private insurers about reimbursement rates.
The test’s original indication was to assess the risk of distant metastasis and prostate cancer-related death, and it can also predict if a patient would benefit from androgen deprivation therapy (ADT). Royce highlighted that up to 60% of intermediate-risk prostate cancer patients could avoid ADT and its side effects, such as brain fog, weight gain, and muscle loss.
In March, the National Comprehensive Cancer Network included Artera as the first AI-based test in its Clinical Practice Guidelines in Oncology.
As reported by Medscape, the AI test was developed from a 2022 study of nearly 22,000 pathology slides from around 7,000 patients. Todd Morgan, MD, Chief of the Division of Urologic Oncology at the University of Michigan and coauthor of the study, said, “This technology is a major advancement. Using digital images to make accurate prognostic estimates is remarkable, and this is the first test across any disease site to do so.”
Artera is now developing a version of the test to guide treatment duration for men with higher-risk prostate cancer and provide prognosis after prostatectomy based on surgical specimens. Currently, the test is based on prostate biopsy samples processed in a central lab, but the company hopes to eventually conduct the test using only digital pathology images.