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FDA Approves AI-Based Software for Screening Assistance in Prostate Cancer
On September 21, 2021, the FDA approved marketing of software dedicated to assisting medical professionals, particularly pathologists, in the detection of suspicious areas in body tissue for cancer, as an adjunct to the review of digitally scanned slide images from prostate biopsies.
Paige Prostate is the first artificial intelligence (AI)-based software designed to identify areas of concern on prostate biopsy images and prevent oversight upon initial review. This informative software refines the diagnosis process for pathologists and their respective patient populations.
This software was reviewed through the FDA’s De Novo premarket review pathway for regulatory, labeling, and performance testing.
The FDA’s authorization stems from data evaluated from a clinical study with 16 pathologists who examined 527 prostate biopsy images (171 cancer and 356 benign) that were digitized through a scanner. Upon each slide observation, pathologists fulfilled two assessments, one with and one without Paige Prostate’s assistance.
Although the study did not evaluate the impact of final patient diagnosis, findings showed that Paige Prostate improved detection of cancer on individual slide images by 7.3% on average in comparison to pathologists’ unassisted reads for whole slide images of individual biopsies with no impact on the read of benign slide images.
Notably, potential risks include false negative and false positive results. However, this issue is mitigated by the device’s purpose being adjunct and by the professional evaluation of a qualified pathologist who acknowledges patient history, may request additional laboratory studies or multiple biopsies prior to rendering a final diagnosis. – Alexa Stoia
