Thazin Nwe Aung, Balazs Acs, Jonathan Warrell, Yalai Bai, Patricia Gaule, Sandra Martinez-Morilla, Ioannis Vathiotis, Saba Shafi, Myrto Moutafi, Mark Gerstein, Benjamin Freiberg, Regan Fulton, David L Rimm
Ki67, a nuclear proliferation-related protein, is heavily used in anatomic pathology but has not become a companion diagnostic or a standard-of-care biomarker due to analytic variability in both assay protocols and interpretation. The International Ki67 Working Group in breast cancer has published and has ongoing efforts in the standardization of the interpretation of Ki67, but they have not yet assessed technical issues of assay production representing multiple sources of variation, including antibody clones, antibody formats, staining platforms, and operators...
July 2021: Modern Pathology