HalioDX

IMMUNOSCORE® COLON Scoring Immune Response to Cancers

for unmatched clinical performance in routine settings



With Immunoscore® Colon, HalioDx provides clinicians a unique and robust decision making tool for patient management based on intra and peri-tumor immune response.

Immunoscore® Colon, the first standardized immune-based assay for the classification of cancer, is available through HalioDx service laboratory*. Oncologists & pathologists have access to :

  • CE-IVD assay in Europe
  • CLIA service for US**
  • RUO (Research Use Only) solution in the rest of the world.

* Refer to Ordering Information part.

** Except California, Florida, Georgia, Kentucky, Maryland, Nevada, New York, Pennsylvania, Rhode Island and Tennessee

Profile

Immunoscore® Colon
Indication: Colon Cancer 
Clinical Utility: Improve the classification of cancer & identify patients at high risk of recurrence
Material: FFPE slides from tumor resection
Target: CD3+ & CD8+ T-cells
Location: Centre and periphery of the tumor 
Technology: Image analysis enhanced Immunohistochemistry
  • Immunoscore® Colon measures the density of two T lymphocyte populations in the center and at the periphery of the tumor: CD3+ and CD8+ T cells. The CE-IVD test provides a better staging of the disease and improve clinical decision-making process for colon cancer patients.
  • The technology used is immuno-histochemistry coupled to advanced Immunoscore® Analyzer for a standardized tissue segmentation and immune cells quantification. Cell densities are then computed to provide the sample’s Immunoscore®.
  • Immunoscore® Colon under its CE-IVD version is one of the first 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.

* Refer to Ordering Information part.

 

 

About Colon cancer (CC):

  • Cancers of the colon and the rectum altogether are the third most common cancer in men and the second in women worldwide. In 2014, 1.4 million new cases of colorectal cancer were diagnosed worldwide, and nearly 700,000 patients died of the disease (Classification of malignant tumors 7th edition, UICC). About 72% of cases arise in the colon and about 28% in the rectum.
  • Today, the TNM staging system (AJCC/UICC) provides the most reliable reference for the routine prognostication and treatment decision for colorectal carcinoma. TNM system describes tumour extension in the primary tumour (T), in the regional lymph nodes (N) and indicates the presence of metastases in distant organs (M).
  • In daily practice and in guidelines, TNM categories are directly linked to treatment strategies and, as such, changes in the TNM staging system have a considerable and direct impact on the cancer care that patients receive. Treatment for colon cancer may involve surgery, chemotherapy/biological therapy or radiation therapy in combination.

Medical Needs :

  • The survival rate at five years is largely correlated with disease stages but in stages II and III, representing almost half of new cases of colon cancers, there are still debates on how to improve adjuvant treatment decisions. The 7th edition of the AJCC TNM system was issued in 2010 to address this issue but still provides incomplete prognostic information (1).
  • In some patients, advanced-stage cancer can remain stable for years, and although rare, partial or full regression of metastatic tumors can occur spontaneously (2). In contrast, relapse, rapid tumour progression and patient death is associated with approximately 20% of TNM stage II colorectal cancer (CRC) patients, despite complete surgical resection and no evidence of residual tumor burden or distant metastasis (2). The challenge is to identify those patients in whom disease will recur.
  • Extensive literature has documented the host immune response against cancer and demonstrated the prognostic impact of the in situ immune cell infiltrate in tumors. The Immunoscore®, which quantifies CD3+ and CD8+ T-cells infiltrates both in the tumor core and in the invasive margin, has been shown to have a significant prognostic value in several cancers.
  • In CRC, it has been demonstrated to significantly improve prognostic accuracy independently of clinical variables for all patients with CRC stages I/II/III (3, 4, 5), and to have superior prognostic power versus the classical TNM staging system.  By evaluating the immune contexture of the tumor, the Immunoscore® Colon assay is aimed at providing a better staging of the disease, hence, an improved clinical decision-making process for colon cancer patients.

ASCO 2017

See press release

Visit ASCO Media library - Abstract

This study validates that Immunoscore® Colon is clinically useful and reliable to identify high risk stage III colon cancer patients

Mayo clinic study key results:

  1. The prognostic value of individual immune markers and of the standardized Immunoscore® Colon test was evaluated in 600 patients stage III colon cancer (CC) treated with adjuvant FOLFOX.
  2. Immunoscore Low (IS 0-1) was associated with worse DFS   (HR=0.64, CI, 0.45-0.92, p=0.015).
  3. These results provide an additional clinical level of evidence and validate the strong prognostic value of the CE-IVD Immunoscore® Colon assay in a retro-prospective US clinical trial cohort.

Poster available in our download center (in the right column).

ASCO 2016

See press release

Visit ASCO Media library - reserved access

This study validates Immunoscore® Colon as a prognostic marker in stage I/II/III colon cancer.

SITC study key results:

  1. Immunoscore® Colon predicted Time To Recurrence (TTR): primary end-point of the study
  2. Immunoscore® Colon also predicted Disease Free Survival (DFS) and Overall Survival (OS)
  3. Immunoscore® Colon was statistically significant in multivariate models including TNM stage
  4. Immunoscore® classification identified a subgroup of high-risk stage II patients that could potentially benefit from adjuvant chemotherapy (n=375 high-risk patients out of 1433 Stage II) (HR (95% CI), .36 (.23-.56), p<.0001)
  5. Immunoscore® Colon is robust and reproducible across centers

Jérôme GALON underlined: “In the era of oncology, notably in immunotherapy, it is now essential to classify cancer patients based on immune parameters. The results of this study conducted by an international consortium has the potential to drive the implementation of the Immunoscore® as a new component for the classification of cancer, designated as TNM-I (TNM-Immune)”.

Immunity 2016

Immunoscore® compared to Microsatellite status

Survival analysis showed that patients with Immunoscore®-High (for highly infiltrated tumors) have a significant prolonged OS (overall survival) and DFS (disease free survival) regardless of their Microsatellite status.

MSI patients with Immunoscore®-Low (low infiltration of the tumor) show a bad clinical outcome, similar to MSS patients with Immunoscore®-Low, while some MSS patients with Immunoscore®-High show a good outcome.

Conclusion of this study was that in multivariate analysis for OS, DFS & TTR, Immunoscore® is significant (p< 0.0001) whereas histopathological parameters & MSI are not.

Microsatellite status & Immunoscore® | From MLECNIK et al., Immunity 2016.

Standardized and validated workflow adapted to your laboratory set-up

* Image analysis from stained slides   ** Image analysis from scanned images

Depending on your laboratory equipment, Immunoscore® Colon* is available in a full service process (performed in HalioDx laboratories) or through a standardized and validated workflow allowing you to perform the Immuno-histochemistry step using the HalioDx Immunoscore® Colon Kit and send either stained slides or images to HalioDx Service Laboratory for Digital Pathology Service and result reporting.

Pathologists have access to a CE-IVD assay in Europe, while a RUO (Research Use Only) solution is available in the Rest of the World.

Interested in ordering Immunoscore® Colon ?

Please download documentation making your selection in the table below

  1. between CE-IVD, CLIA service and RUO assay

  2. between Full Service, Digital Pathology Service from Slides (DPS Service) and Digital Pathology Service from Images (DPI Service).

Then, contact us using the form below.

Full ServiceDPS ServiceDPI Service
Immunohistochemistry using
Immunoscore® Colon Kit
HalioDx LabYour Pathology LabYour Pathology Lab
ScanningHalioDx LabHalioDx LabYour Pathology Lab
Image analysisHalioDx LabHalioDx LabHalioDx Lab
Provided by the pathology lab
to HalioDx
FFPE blocks or
4 unstained slides
Slides stained with
Immunoscore® Colon Kit
Images of the slides
Access documentationCE-IVD RUO CLIACE-IVD RUOCE-IVD RUO

 

* This test is available as a CE-IVD solution in Europe, CLIA service in the US and RUO for Rest of the World.

For academic centers who would like to set up collaborations with HalioDx using Immunoscore® Colon, please contact us using the form below. We will be happy to get back to you to discuss your project.

Reference publications

Immunoscore® & Immunoscore® Colon

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)

More info

Ferris RL, Galon J

Additional Support for the Introduction of Immune Cell Quantification in Colorectal Cancer Classification

J Natl Cancer Inst. 2016

May 12;108(8). pii: djw033.

More info

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.

More info

Galon J et al.

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

J Pathol. 2014

Jan;232(2):199-209.

More info

Galon J et al.

Cancer classification using the Immunoscore: a worldwide task force.

J Transl Med 2012 ;

10 : 205.

More info

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.

More info

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

Onclive TV coverage at ASCO 2016

Jerome Galon on the Prognostic Value of Immunoscore®