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

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.