Increased Repeatability and Reproducibility of Breast Marker Scoring Using Digital Pathology Solutions
Gerardo Fernandez, M.D. is currently the Medical Director for Ventana Medical Systems Digital Pathology in Mountain View, California. Previously Dr. Fernandez was Vice President of R&D and Pathology for Aureon Biosciences and before that held positions at Genzyme Genetics and Impath in New York City. He received his medical degree from Drexel University College of Medicine and did his Anatomical and Clinical Pathology residency as well as two fellowships in Surgical Pathology and Cytopathology at the New York University Medical Center. For the last ten years Dr. Fernandez has spent his career working with digital pathology, primarily leading development of automated systems for quantitating various types of phenotypic expression in multivariate settings.
The standard breast cancer prognostic/predictive IHC panel has become an integral part of the routine evaluation and surgical pathology reporting of breast cancer patients. Although published guidelines recommend estrogen and progesterone receptor status along with Her2 status, the addition of Ki67 and p53 are commonplace. Low thresholds for positivity in ER and PR evaluation may make reproducibility less of an issue for these markers than with Her2, Ki67 and p53, where inter-laboratory and inter-observer robustness is of greater concern. We outline the results of a controlled digital pathology-based workflow protocol for ER, PR, Her2, Ki67 and p53 on inter- and intra-observer concordance, as well as the correlation to Her2 genomic status as determined by fluorescent in-situ hybridization.
Recognition of the added value of a digital pathology solution for robust reproducible grading of a breast cancer marker panel.
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