Adjunct detection on prostate biopsy whole-slide images
Paige Prostate marks a location on a digitized prostate biopsy slide that the model ranks as the most suspicious for cancer, after the pathologist’s own first look. FDA authorized it in 2021 as an adjunct. The output is not the diagnosis. The pathologist still signs out, using the full clinical context and any extra stains they choose to order.
Clinical setting
Surgical pathology laboratories reading hematoxylin-and-eosin prostate needle biopsies that have been scanned on a supported whole-slide scanner.
Tools and vendors
Paige Prostate
Paige FullFocus
What was reported
FDA reported that, across 16 pathologists and 527 slide images, cancer detection on individual slides improved by 7.3% on average versus unassisted reads, with no effect on the read of benign slides. The study did not measure the effect on the final patient diagnosis, which usually rests on more than one core.
Source
U.S. FDA De Novo DEN200080 · Sep 21, 2021 · Year 2021
Vendors including PathAI and Ibex offer algorithms that estimate staining extent, such as a Ki-67 or PD-L1 percentage, on a digitized slide. A pathologist checks the region and the number before it enters the report. This card does not restate concordance percentages, which are assay-specific and easy to over-read. The signed score remains a pathology result, not a model result.
IDx-DR, now marketed as LumineticsCore by Digital Diagnostics, was authorized to screen adults with diabetes for more-than-mild diabetic retinopathy without an eye specialist reading the photo first. A primary care team captures images on a specified retinal camera and the software returns a refer-or-rescreen result. It is not a complete eye examination. Pregnancy and several existing retinal conditions sit outside the labeled use.
LumineticsCore (IDx-DR) · Digital Diagnostics · Topcon NW400
The MASAI trial in Sweden randomly assigned screening mammograms to AI-supported reading or standard double reading without AI. Transpara scored each exam and routed lower scores to a single reader and the highest score to double reading, with detection marks available on higher-risk exams. This card quotes the prespecified interim safety analysis, not a claim that every screening program should switch.