For pathologists that examine tissue biopsies every day, their jobs just got easier when the U.S. Food & Drug Administration (FDA) approved the first artificial intelligence- based software to help detect prostate cancer. The FDA approves the marketing of the software called Paige Prostate by Paige.AI. The software is designed to identify areas of concern on the biopsy image that was not initially reviewed. This will help pathologists to make a diagnosis more quickly, thus saving more lives.
According to the Centers for Disease Control and Prevention (CDC), the most recent incidence data available is 2018 and it states that in the United States, 211,893 new cases of prostate cancer were reported among men, and 31,488 men died of this cancer in the United States. For every 100,000 men, 108 new prostate cancer cases were reported. Heart disease leads as the number one leading cause of death in the United States and cancer is second.
The results from a clinical study of 16 pathologists who examined 527 digitized slide images of prostate biopsies with and without the assistance of Paige Prostate, showed that Paige Prostate’s assistance improved cancer detection on slide images by 7.3% on average.
The potential for a false negative and false positive results is mitigated by the pathologist. The device is meant to assist the pathologist in reviewing the slide images, and the pathologist still takes into account the patient history and other relevant clinical information. Sometimes additional laboratory studies on the samples are performed prior to rendering a final diagnosis.
Along with granting marketing authorization, the FDA creates a new regulatory classification for this type of device. The FDA’s action establishes special controls for devices of this type, including requirements related to labeling and performance testing which provide assurance of safety and effectiveness.