The U.S. FDA has authorized marketing of software to assist pathologists in the detection of areas that are suspicious for cancer as an adjunct to the review of digitally scanned slide images from prostate biopsies. The artificial intelligence (AI)-based software, Paige Prostate, is designed to identify an area of interest on the prostate biopsy image with the highest likelihood of harboring cancer so it can be reviewed further if the area of concern has not been identified on initial review.
“Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment,” says Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “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.”
Paige Prostate is compatible for use with slide images that have been digitized using a scanner. The digitized slide image can then be visualized using a slide image viewer. The FDA evaluated data from a clinical study where 16 pathologists examined 527 slide images of prostate biopsies (171 cancer and 356 benign) that were digitized using a scanner. For each slide image, each pathologist completed two assessments, one without Paige Prostate’s assistance (unassisted read) and one with Paige Prostate’s assistance (assisted read).
While the clinical study did not evaluate the impact on final patient diagnosis, which is typically based on multiple biopsies, the study found that Paige Prostate improved detection of cancer on individual slide images by 7.3% on average when compared to pathologists’ unassisted reads for whole slide images of individual biopsies, with no impact on the read of benign slide images.
The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing.
The FDA granted marketing authorization of the Paige Prostate software to Paige.AI.