- Immunoscore® has confirmed its potential to become a major component of the colon cancer classification at ASCO 2016.
- Immunoscore® Colon is available as a laboratory service in July 2016 and on track to be commercialized as a CE-IVD solution by end of the year.
Marseille, Paris, France, July 7, 2016 - HalioDx SAS, an immuno-oncology diagnostic company, the French National Institute of Health and Medical Research (Inserm) and Inserm Transfert, its subsidiary, today announced the commercialization of Immunoscore® Colon, a unique diagnostic assay for guiding therapeutic decisions in colon cancer.
Based on Immunoscore®, an Inserm technology protected and licensed by Inserm Transfert, HalioDx development team worked on the reagents components of the assay, to guarantee a robust and reliable staining, but also on the image analysis software to render Immunoscore® a straightforward, standardized and quantitative assay.
The very first test, Immunoscore® Colon, will be available in July 2016 through HalioDx service laboratory*. By the end of the year, pathologists will have access to a CE-IVD assay in Europe, while a RUO (Research Use Only) solution will also be available in the rest of the World.
The CE-IVD test will be intended as an aid for clinicians to assess prognosis of colon cancer at diagnosis, in combination with the TNM classification and other relevant clinical and biological patient and tumor features. Immunoscore® Colon has demonstrated its robustness and accuracy in several retrospective studies, including in the recent Immunoscore® Validation Project led by the Society for Immunotherapy of Cancer (SITC) involving 23 pathology centers from 17 countries, where more than 3,800 patient samples were evaluated. Positive results were presented at ASCO 2016 by Dr Jérôme GALON, Research Director at Inserm, Head of the laboratory of Integrative Cancer Immunology, Paris, France and principal investigator of the study.(Press Release & video presentation)
Vincent FERT, CEO of HalioDx comments “This is an important milestone achieved by our teams, demonstrating that the quantitative analysis of immune cells can be performed in a routine setting and the information delivered can be integrated in the routine practice of pathologists and oncologists. Associating the simplicity of immunohistochemistry methodology with advanced image analysis is a powerful concept for providing standardized, objective and quantitative information in the immuno-oncology diagnostics. We are in line with our plan for the commercial launch of Immunoscore® Colon with a first version available in July, as a service performed in our laboratory* and with a CE-IVD solution, available by the end of the year. ”
"Inserm Transfert rapidly realized that the technology Immunoscore® developed by Dr. J. GALON and his team had an outstanding potential in helping physicians to stratify cancer patients and support anti-cancer therapeutic approaches. We were very pleased to sign a licensing agreement with HalioDx on this unique technology in late 2014. 18 months later, we are delighted to see Immunoscore® will be available for the oncologists community by the end of the year." added Pascale AUGÉ, CEO of Inserm Transfert.