FDA authorizes AI-based software for prostate cancer detection

Paige Prostate AI-based software provides pathologists with a supplementary assessment of prostate biopsy images that identifies the area with the highest likelihood of harboring cancer.

The FDA has authorized the marketing of Paige Prostate, an AI-based software platform to help pathologists identify prostate cancer when they review slide images from prostate biopsies.1

The standard biopsy review process involves the pathologist examining digitally scanned slide images from prostate biopsies to find areas that are suspicious for cancer. Paige Prostate provides a supplementary assessment of the image and locates the area with the highest probability of harboring cancer. The pathologist can then examine this specific area further if they did not identify it on their initial assessment.

“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,” 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, stated in a press release. “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.”

In making its decision to authorize the marketing of Paige Prostate, the FDA reviewed the results of a clinical study involving 16 pathologists who assessed 527 slide images of prostate biopsies. The images had been digitized with a scanner and included 171 with cancerous tissue and 356 with benign tissue. All pathologists performed 2 assessments of each slide image, one with the assistance of Paige Prostate and one without.

The results showed that detection of cancer on individual slide images was improved by an average of 7.3% with the assistance of Paige Prostate versus the pathologists’ unassisted reads. There was no impact on the assessment of the benign slide images. Of note, the impact of Paige Prostate on final patient diagnosis was not an end point of the study, as that is typically determined following multiple biopsies.

The FDA noted that false negative and false positive results are potential risks with Paige Prostate. However, the agency maintained that these risks are mitigated by the fact that the device is only a supplementary tool used to assist pathologists who are able to provide their own independent evaluation that accounts for a broad spectrum of relevant clinical information. The risks of false negatives/positives are also mitigated by the pathologists’ capacity to conduct additional laboratory studies on the biopsy samples before making a final diagnosis.

Paige Prostate, which is marketed by Paige.AI, was reviewed by the FDA through its De Novo premarket review pathway, which is specifically for novel devices that are considered by agency to be low- to moderate-risk.


1. FDA Authorizes Software that Can Help Identify Prostate Cancer. Published online September 21, 2022. Accessed September 21, 2022. https://bit.ly/3lKAEGb.