FDA Approves First AI Device to Assist With Prostate Cancer Detection

The FDA authorized the marketing of Paige Prostate, the first ratification-intelligence-based software designed to identify areas with high likelihood of cancer on images from a prostate biopsy.

The FDA authorized the marketing of Paige Prostate, the first ratification-intelligence (AI)-based software designed to identify areas with high likelihood of cancer on images from a prostate biopsy, according to a press release by the FDA.1

Paige prostate is an AI pathology product designed to find small foci that may be cancerous in order to better assist the pathologists. It is compatible with digitized slide images and can be viewed through a slide image viewer.1-2

“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 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, in a press release.1 “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.”

The approval is based on a study of 527 slide images of prostate biopsies. Of the 527 slides, 171 were cancerous and 356 were benign. They were exampled by 16 pathologists. Each pathologist completed an unassistated read, meaning they did not use Paige Prostate, and an assisted read, meaning they did use the AI technology. Data was collected from over 150 institutions in order to ensure that it was generalized.1-2

According to the FDA, the technology improved cancer detection by 7.3% on average compared to the unassistated reads. This increased accuracy from 89.5% to 96.8%. Additionally, the device reduced false negatives by 70% and false positives by 24%. The device had no impact on the read of benign slides.1

The potential risks associated with Paige Prostate include false positives and false negatives. However, this can be mitigated by the fact that devices should only be used as an adjunct and by professional evaluation by a qualified pathologist who is able take into account relative factors such as patient history.1

“This landmark approval of Paige Prostate by the FDA marks the beginning of a new era in the use of computer-assisted diagnostics for pathology. The approval reflects the rigor with which Paige Prostate has been validated, as the first clinical-grade AI technology to assist pathologists in the interpretation of routinely stained slides. This innovation paves the way for the introduction of numerous future tools to help standardize pathology diagnosis, expedite the diagnostic process, and provide pathologists and patients greater comfort from the added scrutiny of their pathology slides,” said David Klimstra, MD, co-founder, and chief medical officer at Paige in a press release. “FDA approval allows pathology laboratories to introduce this diagnostic tool into their clinical workflow to help make pathologists more accurate, more reproducible, and more efficient, which will allow them to focus their attention on the most critical aspects of establishing the diagnosis.”2

1.FDA authorizes software that can help identify prostate cancer. News release. FDA. September 21, 2021. Accessed September 24, 2021. https://bit.ly/3kAFZk2.
2.Paige receives first ever FDA approval for AI product in digital pathology. News release. Paige. September 22, 2021. Accessed September 24, 2021. https://bit.ly/3AzM0Df