Artera, a company that develops multimodal AI-based prognostic and predictive cancer tests, has been granted Breakthrough Device Designation by the FDA for its ArteraAI Prostate, an AI-enabled tool designed to assist clinicians in making risk-based decisions for patients with localized prostate cancer.
ArteraAI Prostate analyzes digital pathology images of a patient’s prostate cancer biopsy slide to prognosticate long-term outcomes, including 10-year risk of distant metastasis and prostate-cancer specific mortality.
The aim is to help clinicians determine the most appropriate treatment option.
According to the company, its biomarker test uses an algorithm that evaluates digital images from a patient's biopsy and their clinical data.
The AI combines that information to determine a patient's prognosis and predict whether they may benefit from a specific therapy.
"This designation is a powerful validation of our software's potential to transform how we treat cancer," Andre Esteva, CEO of Artera, said in a statement.
"We are proud that the FDA has recognized our innovative technology platform and we’re excited to be advancing the frontier of oncology by delivering differentiated and clinically relevant tools that can help save more lives."
THE LARGER TREND
In June, Artera launched its DIRECT-AI registry study designed to assess how the ArteraAI Prostate Test influences treatment decision-making between clinicians and patients with localized prostate cancer.
The study aimed to monitor participants to evaluate their long-term cancer outcomes.
According to the company, the study is divided into two phases.
Phase one captures real-world insights into how the Artera Prostate Test informs clinical decision-making with feedback gathered from participating clinicians and patients.
The second phase monitors long-term health outcomes at key intervals of two and five years, examining endpoints such as distant metastasis, survival rates and treatment effectiveness.
At its launch in 2023, Artera announced a $90 million investment. The company used the funds to distribute its prostate cancer test and develop tests to assist in personalizing therapy options for other types of cancers.
