IMMUNOSCORE® COLON Scoring Immune Response to Cancers

for unmatched clinical performance in routine settings

Why Immunoscore® Colon?

Immunoscore® Colon is an in vitro diagnostic assay to assess the risk of relapse in colon cancer patients.

By measuring the density of CD3+ and CD8+ T lymphocyte populations in the center and at the periphery of the tumor, Immunoscore® Colon is a key risk factor to guide treatment strategies for stages II and III colon cancer (CC) patients.

a) SITC International study results, The Lancet May 2018
b) N0147 study results, ASCO 17 & ASCO GI 18


Immunoscore® Colon
Material: FFPE block or FFPE slides from tumor resection
Target: CD3+ & CD8+ T cells 
Location: Center and periphery of the tumor
Technology: Digital pathology

The Immunoscore® scoring has been defined in a large international SITC-led retrospective validation study conducted on more than 2500 St I-III CC patients (Pagès et al, The Lancet May 2018).

Immunoscore® Colon under its CE-IVD version is the first immune scoring diagnostic tests used in routine by pathology labs leveraging advanced image analysis. The accuracy and robustness of the test relies on precise counting of positive immune cells in predefined regions and automatic calculation of Immunoscore® for each patient based on specific algorithm.

Download general presentation of Immunoscore® Colon

Download Immunoscore® Colon white paper

Clinical Utility

Immunoscore® Colon is a test predicting the risk of relapse of patients with localized CC to help guiding treatment strategies. By evaluating the immune reaction at the tumor site, it provides independent and superior prognostic value to usual risk factors.

Relative variable contribution

Pagès et al, The Lancet May 2018

This information supports decision about adjuvant chemotherapy need (stage II) and duration of treatment (stage III).

In the large Immunoscore® SITC study (more than 2,500 stage I-III patients), Immunoscore® was strongly predictive of the patient outcome and surpassed the TNM classification prognostic performance.

Focusing on stage II (n = 1,434 patients), Immunoscore® identified a subgroup of high-risk stage II patients (23%) who may benefit from chemotherapy.



Patients with low Immunoscore® had a reduced survival irrespective of their microsatellite status.

Immunoscore® Low was observed in 27% of patients with MSS tumours  and in 14 % of MSI cases.

Following international IDEA collaboration results, it has been suggested that the duration of adjuvant FOLFOX or CAPOX chemotherapy should be guided by a risk-based approach, based on T and N risk groups (T1-T3 N1 versus T4 or N2).

Immunoscore® has been tested on 600 resected tumors of stage III CC patients from the FOLFOX arm of the prospective NCCTG N0147 clinical trial. This retro-prospective study demonstrated that Immunoscore-Low was associated with a higher risk of recurrence including among the low risk T1-3 N1 subgroup with significantly worse 3-years RFS (78% vs 92%, see figure below). These data underscore the limitations of T and N staging and provide validation for Immunoscore® Colon to identify high risks T1-3 N1 patients for whom a 3 months chemotherapy course might be detrimental.

A comprehensive body of clinical evidence

Immunoscore® surpasses TNM for prediction of tumor recurrence and survival in CRC patients.

Galon J et al. - Science 2006

Pages F et al. - JCO 2009

Mlecnik B et al. - JCO 2011

Galon J et al. - ASCO 2016

Kirilovsky A et al. Int Immunol 2016

Pagès et al, The Lancet May 2018

Stage II CC patients with Immunoscore-Low have a higher risk of recurrence.

Pagès et al, The Lancet May 2018

Immunoscore® is a stronger predictor of survival than MSI in CC.

Mlecnik B et al. - Immunity 2016

Pagès et al, The Lancet May 2018

Stage III CC patients with Immunoscore-High have a lower risk of recurrence regardless of the MSI status.

Sinicrope FA et al. - ASCO 2017 - Poster (manuscript in preparation)

Immunoscore® provides prognostic information in low and high T/N risk subsets of Stage III CC.

Sinicrope, F. A et al. ASCO GI J Clin Oncol 36, 2018 (suppl 4S; abstr 614) (manuscript in preparation)


HalioDx is conducting multiple studies to further support the Immunoscore®-based risk assessment for CC patients management.

How to Order

Immunoscore® Colon workflow

Interested in ordering Immunoscore® Colon? contact us

Scientific Data

Selected videos on Immunoscore® Colon


Selected publications

Pagès et al.

International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study

The Lancet, 2018

May 10, 2018

More info

Mlecnik B et al.

Comprehensive Intrametastatic Immune Quantification and Major Impact of Immunoscore on Survival.

J Natl Cancer Inst. 2018 ;

Jan 1;110(1). doi: 10.1093

More info

Berghoff AS et al.

Density of tumor-infiltrating lymphocytes correlates with extent of brain edema and overall survival time in patients with brain metastases.

Oncoimmunology 2016 ;

Jun 9;5(1):e1057388

More info

Kirilovsky A et al.

Rational bases for the use of the Immunoscore in routine clinical settings as a prognostic and predictive biomarker in cancer patients

Int Immunol. 2016

doi: 10.1093/intimm/dxw021

More info

Hermitte F

Biomarkers immune monitoring technology primer: Immunoscore® Colon

Journal for ImmunoTherapy of Cancer 2016

DOI: 10.1186/s40425-016-0161-x

More info

Galon J et al

Validation of the Immunoscore (IM) as a prognostic marker in stage I/II/III colon cancer: Results of a worldwide consortium-based analysis of 1,336 patients.

2016 ASCO Annual Meeting

J Clin Oncol 34, 2016 (suppl; abstr 3500)

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Mlecnik B et al.

Integrative Analyses of Colorectal Cancer Show Immunoscore Is a Stronger Predictor of Patient Survival Than Microsatellite Instability.

Immunity. 2016 ;

Mar 15;44(3):698-711.

More info

Mlecnik B et al.

The tumor microenvironment and Immunoscore are critical determinants of dissemination to distant metastasis.

Sci Transl Med. 2016 ;

24 Feb 2016, Vol. 8, Issue 327, pp. 327ra26.

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Galon J et al.

Towards the introduction of the 'Immunoscore' in the classification of malignant tumours

J Pathol. 2014


More info

Galon J et al.

Cancer classification using the Immunoscore: a worldwide task force.

J Transl Med 2012 ;

10 : 205.

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Mlecnik B et al.

Histopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction.

J Clin Oncol 2011 ;

29 : 610-8.

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Pagès F al.

In situ cytotoxic and memory T cells predict outcome in patients with early-stage colorectal cancer.

J Clin Oncol 2009 ;

27 : 5944-51.

More info

Galon J et al.

Type, density, and location of immune cells within human colorectal tumors predict clinical outcome.

Science 2006 ;

313 : 1960-4.

More info

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