Artera Secures FDA Breakthrough Designation for AI-Powered Prostate Cancer Test

Artera, a developer of multimodal AI-based prognostic and predictive cancer tests, has achieved a significant regulatory milestone with the FDA granting Breakthrough Device Designation for its ArteraAI Prostate test. This AI-enabled diagnostic tool represents a new approach to personalized cancer care by analyzing digital pathology images from prostate cancer biopsy slides to help clinicians predict long-term patient outcomes.

The ArteraAI Prostate test works by examining digital images of a patient's prostate cancer biopsy slide to prognosticate critical long-term outcomes, including 10-year risk of distant metastasis and prostate cancer-specific mortality. The technology employs an algorithm that evaluates both the digital biopsy images and the patient's clinical data, combining these inputs to determine prognosis and predict whether patients may benefit from specific therapeutic approaches.

"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 FDA designation comes as Artera continues to build clinical evidence for its technology. In June, the company launched its DIRECT-AI registry study to assess how the ArteraAI Prostate Test influences treatment decision-making between clinicians and patients with localized prostate cancer. The study follows a two-phase approach: phase one captures real-world insights into how the test informs clinical decision-making with feedback from participating clinicians and patients, while phase two monitors long-term health outcomes at two and five-year intervals, examining endpoints such as distant metastasis, survival rates, and treatment effectiveness.

The company's progress builds on strong financial backing received since its 2023 launch, when Artera announced a $90 million investment. These funds have been directed toward distributing its prostate cancer test and developing similar AI-powered tests to assist in personalizing therapy options for other cancer types. The Breakthrough Device Designation now positions Artera to accelerate its path to market while working closely with the FDA to meet regulatory requirements for this innovative diagnostic tool.

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