Immunoscore® in the WHO Classification
of Digestive System Tumours

Immune response is  now part of the Essential and Desirable Diagnostic Criteria for Colorectal Cancers in the 5th edition of the WHO Classification of Tumours

Marseille, France, March 4, 2020, 6 PM CET - The World Health Organization (WHO), in its latest edition of the Digestive System Tumours (5th edition), introduced immune response as an essential and desirable diagnostic criteria for colorectal cancer. Commercialised by HalioDx in more than 20 countries for patients with localized colon cancer, Immunoscore® is an in vitro diagnostic test quantifying the immune response for predicting cancer recurrence and personalizing care decisions.

The standardized method used in the SITC validation effort (i.e. Immunoscore®) is referenced in the WHO Classification of Tumours, 5^th edition, as the most recent evidence of the immune response prognostic power in colon cancer (Pagès et al. Lancet 2018). Immune response assessment is now an essential complement to the traditional TNM¹ staging system in colon cancer, Immunoscore^® being the reference assay for its evaluation.

Dr Jérôme Galon, the inventor of Immunoscore® says: “The introduction of the Immune response assessment for colon cancer patients in the WHO classification rewards 15 years of translational research efforts on Immunoscore® with a significant impact on standard of care. This effort is a collective success including numerous French and international collaborators. We are now investing significant efforts in demonstrating Immunoscore® clinical utility, beyond colon cancer, in a broad range of indications”.

Vincent FERT, CEO of HalioDx, comments: “The recognition by the WHO board of the importance of the immune response assessment in colorectal cancer is a key landmark for Immunoscore® and HalioDx. It supports our efforts to make this outstanding technology available to improve cancer care worldwide.”

The work on Immunoscore was initiated at the French National Institute of Health and Medical Research (INSERM) (Galon et al Science 2006), and it’s international validation supported by the Society for ImmunoTherapy of Cancer (SITC) (Pagès et al. Lancet 2018).

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About Immunoscore®

Immunity Assessed, Personalized Treatment

Evaluated as an essential and desirable diagnostic criteria by the WHO, immune response assessment is becoming now the necessary complement to the traditional cancer staging system in the digestive system tumours and Immunoscore® is the diagnostic standard to perform this evaluation.

Today, Immunoscore® includes a unique family of immune-based assays, ranging from diagnostic tests such as Immunoscore^® Colon (CE-marked In Vitro Diagnostic and CLIA compliant) and Immunoscore^® for clinical research. At the forefront of digital pathology and spatial omics, HalioDx Immunoscore® assays extract unique information from cancer tissue to deliver precision immunotherapy of cancer.

Immunoscore® is commercially available in more than 20 countries.

About HalioDx

The Immune Response to Cancer Diagnostics

HalioDx is an immuno-oncology diagnostic company providing oncologists and Biopharma  with first-in-class immune-based diagnostic products and services to guide cancer care and contribute to precision medicine in the era of immunotherapy and combination therapies.

Thanks to the pioneering work of Dr Jérôme Galon, HalioDx provides a unique range of immune scoring solutions – notably with the flagship Immunoscore® assay - allowing the assessement of the immune contexture of tumor, a key determinant of patient outcomes and response to cancer treatments (from preclinical stage to approved therapies).

To address the needs of Biopharmas, HalioDx has developed the Immunogram, a platform integrating Immunoscore® assays, innovative technologies such as Multiplex Spatial Tissue Analysis (Brightplex®) and molecular testing (NGS, Immunosign® Gene Expression Signatures).

HalioDx has an experienced team of more than 170 employees, CLIA-certified laboratories and compliant facilities in Europe and in the US to develop, manufacture, register and market in vitro diagnostic (IVD) products. The company co-founded the European immunology cluster Marseille Immunopôle (MI).

For more information, please visit our websites www.haliodx.com and www.immunoscore-colon.com and follow the company on Twitter @HalioDx and Linkedin https://www.linkedin.com/company/haliodx/.

HalioDx® is a registered trademark of HalioDx. Immunoscore® is a registered trademark of Inserm licenced to HalioDx.

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¹ T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body).

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