Artera, the Los Altos, California–based developer of tools to diagnose cancer, has launched the first artificial intelligence (AI) test to guide patients in making informed decisions between active surveillance and active treatment based on an analysis of digital pathology images.
Trevor Royce, MD, MPH, senior medical director of Artera, said the new version of the ArteraAI Prostate Test helps patients with low-risk (Grade Group 1/Gleason 6) to favorable intermediate-risk (Grade Group 2/Gleason 3+4) prostate cancer choose between treatment or active surveillance.
The test estimates how a patient’s cancer may progress and predicts the benefit of treatment for localized prostate cancer.
“The prognostic performance of the test has now been validated in a diverse cohort of patients, including those who have undergone active surveillance, radiation therapy, or had a radical prostatectomy,” said Dr. Royce, a faculty member in radiation oncology at Wake Forest University School of Medicine in Winston-Salem, North Carolina. “The prognostic risk result reflects the patient’s prognosis regardless of the treatment path chosen.”
Dr. Royce said the new test predicts the risk for developing distant metastasis in 10 years. For the population considering active surveillance, it also can predict the likelihood their cancer will show more aggressive features. The test does not make a clinical recommendation, he added.
“Ultimately, that’s a very personal decision between the patient and their physician, and we view it as supporting that decision-making process,” he said.
The test is available in all states but New York and California, where the company is now, in discussions with regulators for approval, according to Dr. Royce. He said the company is in discussion with private insurers to set reimbursement and payment rates. In January 2024, Medicare set a payment rate of $700 for the AI test, which carries no out-of-pocket costs for patients.
The first indication for the test was for localized prostate cancer, prognosticating the risk for distant metastases and death from prostate cancer. It can also predict if an individual will benefit from androgen deprivation therapy (ADT). Dr. Royce said up to 60% of patients with intermediate risk prostate cancer now can avoid ADT and its serious side effects, such as brain fog, weight gain, and reduction in muscle mass.
In March, the National Comprehensive Cancer Network, an alliance of 33 cancer centers included Artera as the first AI test in its Clinical Practice Guidelines in Oncology.
Dr. Royce said active surveillance is a new application of the test. The test was initially developed on a foundational study of almost 22,000 pathology slides from nearly 7000 patients published in npj Digital Medicine in 2022.
Todd Morgan, MD, chief of the Division of Urologic Oncology at the University of Michigan in Ann Arbor, and coauthor of the foundational study, said the AI test adds another layer of data to making clinical decisions for lower-risk patients.
“The technology is a big deal. The ability to use digital images to make accurate prognostic estimates is pretty remarkable, and this is the first test in any disease site to do this,” Dr. Morgan said. “Ultimately, this means tests may someday be performed by just sending images rather than sending actual tissue to an outside laboratory. Is the AI test dramatically more accurate than the genomic platforms? That’s TBD [to be determined].”
Dr. Royce said Artera is now working on a version of its test to inform men with higher-risk prostate cancer how long ADT should last and what the prognosis is for patients who have undergone prostatectomy based on their surgical specimen. The current test uses samples from the prostate biopsy, which are processed in a central lab.
Dr. Royce said the company would like to eventually perform the test using digital images of pathology slides only.
Dr. Morgan reported no conflicts of interest.
A version of this article first appeared on Medscape.com.