Immunoscore®: A Diagnostic Assay for Clinical Management of Colon Cancer

Abstract

Immunoscore® is an in vitro diagnostic assay that is designed to predict the risk of relapse in patients with early-stage colon cancer, thus helping to guide treatment strategies. Immunoscore has CE-IVD status in the EU, is CLIA certified in the USA, and is commercially available in many other countries worldwide. It is designed to be used in conjunction with TNM staging. Immunoscore uses digital images of tumour samples and advanced software to quantify the densities of CD3+ and CD8+ lymphocytes in defined regions of the tumour (i.e. core tumour and the invasive margin). A risk score is calculated, with a lower Immunoscore (i.e. lower densities) corresponding to a higher risk of recurrence. In an international, retrospective, validation study led by the Society for Immunotherapy of Cancer (SITC), Immunoscore was found to be robust, reproducible, quantitative and standardized, providing a reliable estimate of the risk of recurrence. The clinical utility of Immunoscore has been validated in the SITC-led study and in several supportive studies in which Immunoscore predicted survival, optimal treatment duration and relapse in patients with colon cancer.

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Acknowledgements

During the review process, the manufacturer of Immunoscore® was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Hannah A. Blair.

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The preparation of this review was not supported by any external funding.

Conflict of interest

Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

Enhanced material for this Adis Diagnostic Profile can be found at https://doi.org/10.6084/m9.figshare.11959206.

The manuscript was reviewed by:D. Páez, Medical Oncology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; M. Trabelsi, Department of Human Genetics, Faculty of Medicine, University of Tunis El Manar, Tunis, Tunisia; P. Waring, Department of Pathology, University of Melbourne, Melbourne, VIC, Australia.

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Blair, H.A. Immunoscore®: A Diagnostic Assay for Clinical Management of Colon Cancer. Mol Diagn Ther 24, 365–370 (2020). https://doi.org/10.1007/s40291-020-00459-6

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