Ki-67 Proliferation Index Assessment in Gastroenteropancreatic Neuroendocrine Tumors by Digital Image Analysis With Stringent Case and Hotspot Level Concordance Requirements.

Ki-67 measurement by DIA is highly correlated with expert-assessed values. However, close concordance by strict criteria (>80% within ±0.2xKi-67) is not seen with DIA-vs-expert or expert-vs-expert comparisons. The results show analytic noninferiority and support widespread adoption of carefully optimized and validated DIA Ki-67.