The Food and Drug Administration has authorized marketing of AI-based software that helps pathologists detect 7 percent more cases of prostate cancer than they would catch otherwise by analyzing images from patient biopsies.
Called Paige Prostate, the AI flags potentially cancerous areas in prostate biopsy images for further review by pathologists if they aren’t identified in an initial review.
“Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment.”
The FDA approved the software after evaluating a clinical study in which 16 pathologists examined 527 images of prostate biopsies—171 cancerous and 356 benign—then assessed the images a second time with the help of Paige Prostate.
The study found that Paige Prostate improved cancer detection by 7.3 percent compared to assessments without the software, and had no effect on the analysis of benign biopsies.
“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 Stenzel.
Paige Prostate was created by Paige.AI, a diagnostic software company started in 2017.