Analytical Comparison of Commonly Used Laboratory-Developed Tests for the Assessment of Ki-67 in Breast Carcinoma With a Food and Drug Administration-Approved Benchmark.

Sunil Badve¹, Jason S White², Francisco Sapunar², Kelli Thoele², Sameera R Wijayawardana², Xiaoxian Li³, Michael F Press⁴, Souzan Sanati⁵, Kyle C Strickland⁶, Lani Kai Clinton⁷, David Gutman³, Patrick Frey⁸, Tobias Lang⁸, Aaron M Gruver²

¹Department of Pathology, Emory University School of Medicine, Atlanta, Georgia. Electronic address: sbadve@emory.edu.

²Eli Lilly and Company, Indianapolis, Indiana.

³Department of Pathology, Emory University School of Medicine, Atlanta, Georgia.

⁴USC Norris Comprehensive Cancer Center, Los Angeles, California.

⁵Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California.

⁶Labcorp Oncology, Durham, North Carolina; Department of Pathology, Duke University Medical Center, Duke Cancer Institute, Durham, North Carolina.

⁷PathAI, Boston, Massachusetts.

⁸Mindpeak, Hamburg, Germany.

PubMed DOI

Abstract

Ki-67 immunohistochemistry (IHC), a commonly used assay for breast cancer risk prognostication, has significant interlaboratory heterogeneity. This study assessed the impact of antibody clones by comparing the Ki-67 IHC MIB-1 pharmDx assay (Dako Omnis; Agilent Technologies) with clones MIB-1 (Dako Autostainer Link 48 platform), K2 (Leica BOND-III platform), and 30-9 (Ventana BenchMark ULTRA platfo…

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