First Approved AI Digital Pathology for Prostate Cancer
Paige Prostate is the 1st FDA-Approved AI for prostate cancer detection.
Posted September 25, 2021 | Reviewed by Kaja Perina
Artificial intelligence (AI) machine learning is rapidly transforming health care by powering new diagnostic tools for clinicians and medical professionals. In a historic move this week, the U.S. Food and Drug Administration (FDA) authorized the marketing of an AI machine learning software called Paige Prostate—the first approved AI-based software that identifies prostate cancer to assist pathologists.
The FDA De Novo pre-market review pathway is for new types of devices that are either low or moderate risk. With FDA De Novo approval, the new device is authorized for marketing in compliance with regulatory controls.
“The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health in a statement.
Prostate cancer is one of the most common cancer in American men, second only to skin cancer—about 1 out of 8 males in the U.S. will be diagnosed with prostate cancer during his lifetime according to The American Cancer Society (ACS). Additionally, the ACS estimates that in 2021 prostate cancer will cause over 34,000 deaths with more than 248,000 new cases in the United States. Approximately 1 out of 41 American males will die of prostate cancer—it is the second leading cause of cancer deaths in U.S. males after lung cancer the ACS reports.
“Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day. Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment,” said Stenzel.
According to the FDA statement, the study used data from 16 pathologists examining 527 slide images of digitized prostate biopsies that were scanned. Among the slides, 356 were benign, and 171 were cancerous. Each of the slides was assessed twice by the pathologists—once using Paige Prostate’s assistance, and one without.
The clinical study submitted to the FDA demonstrated that pathologists using Paige Prostate increased performance by over seven percentage points in accuracy from 89.5 percent to 96.8 percent for detection of cancer. Moreover, the clinical study showed that non-specialized pathologists were as accurate as prostate specialist who were not using the software.
With this new FDA approval, AI-based software is making significant inroads in shaping the future of assistive tools for detecting diseases.
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