Journal Article
. 2021 Mar; 29(7):479-493.
doi: 10.1097/PAI.0000000000000930.

Quantitative Image Analysis for Tissue Biomarker Use: A White Paper From the Digital Pathology Association

Haydee Lara 1 Zaibo Li 2 Esther Abels 3 Famke Aeffner 4 Marilyn M Bui 5 Ehab A ElGabry 6 Cleopatra Kozlowski 7 Michael C Montalto 8 Anil V Parwani 2 Mark D Zarella 9 Douglas Bowman 10 David Rimm 11 Liron Pantanowitz 12 
  • PMID: 33734106
  •     137 References
  •     1 citations


Tissue biomarkers have been of increasing utility for scientific research, diagnosing disease, and treatment response prediction. There has been a steady shift away from qualitative assessment toward providing more quantitative scores for these biomarkers. The application of quantitative image analysis has thus become an indispensable tool for in-depth tissue biomarker interrogation in these contexts. This white paper reviews current technologies being employed for quantitative image analysis, their application and pitfalls, regulatory framework demands, and guidelines established for promoting their safe adoption in clinical practice.

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A Validation Study of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry Digital Imaging Analysis and its Correlation with Human Epidermal Growth Factor Receptor 2 Fluorescence In situ Hybridization Results in Breast Carcinoma.
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Comparison of Four PD-L1 Immunohistochemical Assays in Lung Cancer.
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Reliance on hormone receptor assays of surgical specimens may compromise outcome in patients with breast cancer.
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Highly Cited. Systematic Review.
MIQuant--semi-automation of infarct size assessment in models of cardiac ischemic injury.
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Automated Tumour Recognition and Digital Pathology Scoring Unravels New Role for PD-L1 in Predicting Good Outcome in ER-/HER2+ Breast Cancer.
Matthew P Humphries, Sean Hynes, +13 authors, Niamh E Buckley.
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Optimizing HER2 assessment in breast cancer: application of automated image analysis.
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PD-L1 Testing in Guiding Patient Selection for PD-1/PD-L1 Inhibitor Therapy in Lung Cancer.
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Advances in Imaging Modalities, Artificial Intelligence, and Single Cell Biomarker Analysis, and Their Applications in Cytopathology.
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