Table 1.

Consensus Immunoscore characteristics for colorectal cancer classification.

Good biomarkerImmunoscore characteristics
FeasibleEstablished pathology techniques, using two regular whole-slide FFPE sectionsYes
RoutineTechnique to be performed by pathologist using bright field and precise cell evaluationYes
RapidAutostainers, scanner, digital pathology reduces the time to perform an ImmunoscoreYes
RobustTwo strong membrane stainings, with no background, allowing the enumeration of individual cellsYes
ReproducibleInterobservers' variability is removed by the use of digital pathology, taking into account cell location and counts (14)Yes
SimpleAutomatized immunochemistryYes
StandardizedStandardized operating procedure, worldwide consensus Immunoscore, approved test for clinical use (CE-IVD)Yes
Pathology-basedPathologist expertise to validate cell type, cell location, and cell counts performed by digital pathologyYes
PowerfulImmunoscore has the highest prognostic value among all known prognostic parameters, including Cox multivariate with TNM classification (1) (7) (14)Yes
QuantitativePrecise cell density (cell number/surface area)Yes
ValidatedWorldwide consensus Immunoscore study validated the power and reproducibility (14)Yes
IVDApproved for in vitro diagnostic for clinical use in colon cancerYes
FDANot yetNo
CLIAAvailable within U.S.-certified CLIA laboratoriesYes
Classification (WHO, UICC, AJCC, NCCN)Not yetNo
ReimbursementNot yetNo
  • Note: The first column shows the desired features of a good biomarker (feasible, routine, rapid, robust, reproducible, simple, standardized, pathology-based, powerful, quantitative, validated), which are all satisfied by the consensus Immunoscore (right column).

  • Abbreviations: AJCC, American Joint Committee on Cancer; CLIA, Clinical Laboratory Improvement Amendments; FDA, Food and Drug Administration; IVD, in vitro diagnostic; NCCN, National Comprehensive Cancer Network; UICC, Union Internationale Contre le Cancer; WHO, World Health Organization.