Artificial intelligence-based software approved by FDA to assist in screening of 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. This software is to be used 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. 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. There was 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 software being used as an adjunct and by the professional evaluation of a qualified pathologist who takes into consideration the patient’s history and may request additional laboratory studies or multiple biopsies before rendering a final diagnosis.
ClinicalOMICS, Sept 22,2021
