Digital pathology and clinical AI firm Paige has published the results of a pivotal study demonstrating accuracy gains in pathologists’ diagnosis of prostate cancer when using Paige Prostate Detect, an FDA-authorised AI software that assists pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies.
The results of the study have been published in the Archives of Pathology & Laboratory Medicine and are available online here.
The study was designed to compare the diagnostic accuracy of pathologists reviewing images of prostate biopsies for the presence of prostate cancer with and without the assistance of Paige Prostate Detect. In the study, pathologists were shown to increase approximately eight percentage points in sensitivity in correctly diagnosing cancer (from 88.7% to 96.6%) with an increase in specificity as well (from 97.3% to 98%). This represents a 70% reduction in false negative diagnoses and a 24% reduction in false positive diagnoses.
On a whole slide image with an ISUP Group 4 cancer involving 2% of tissue (c, pictured above), Paige Prostate Detect indicates a focus of interest that is most likely to harbour cancerous tissue (d). The tissue was misclassified as benign by 12 pathologists and deferred by one pathologist. A benign seminal vesicle was misclassified as cancer by five pathologists and deferred by three in the study (a) (b), while Paige Prostate Detect correctly classified the image as benign. (Photo: Paige)
Both non-specialist pathologists and specialist pathologists saw statistically significant sensitivity gains, with non-specialist pathologists showing a sensitivity of detection with assistance of Paige Prostate Detect similar to that of specialist pathologists. There was no statistical significance between improvements of pathologists who reviewed slides on site or remotely, and there were no significant differences in performance across patient age, race and ethnicity.
“These findings show Paige Prostate Detect is a robust AI software that can be used broadly in clinical practice to provide information physicians need to guide the accurate diagnosis of prostate cancer,” said David Klimstra, MD, Founder and Chief Medical Officer at Paige. “While specialist pathologists are critical, they may not be available at every hospital and laboratory. By providing non-specialist pathologists with Paige Prostate Detect, we are able to give them a user-friendly tool that serves as a second pair of eyes to improve confidence in the diagnostic process. In turn, this heralds a revolution in how pathology is practiced and reinforces the central role pathologists play in patient care.”
Paige Prostate Detect was tested on a wide range of tissue samples to simulate the cases pathologists often encounter in routine clinical practice. The dataset included 610 de-identified prostate needle biopsy whole slide images stained with H&E from 218 different institutions worldwide. Additionally, the data included a mix of hard and easy cases and was enriched with small tumour foci to challenge the system with lesions that can be overlooked by pathologists.