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Immunoscore® Colon is available as a CE-IVD solution

• Immunoscore® Colon is the first standardized immune‐based assay for the classification of cancers

• Immunoscore® has been validated by the Immunoscore® worldwide consortium, led by the SITC (ASCO 2016)

• Immunoscore® is a superior predictor of survival than microsatellite instability

 

  • Immunoscore® Colon is the first standardized immune‐based assay for the classification of cancers
  • Immunoscore® has been validated by the Immunoscore® worldwide consortium, led by the SITC (ASCO 2016)
  • Immunoscore® is a superior predictor of survival than microsatellite instability

HalioDx SAS, an independent immuno-oncology diagnostic company, today announced that its Immunoscore® Colon, a unique diagnostic assay for guiding therapeutic decisions in colon cancer, is available as a CE-IVD solution in Europe.

Immunoscore® Colon CE-IVD test is intended as an aid for clinicians to assess prognosis of primary colon cancer at diagnosis, in combination with the TNM classification and other relevant clinical and biological features. By evaluating the immune contexture of a patient’s colon tumor, the test can determine the likelihood that the cancer cells will spread and cause the disease to recur after surgery. In particular, Immunoscore® Colon enables healthcare professionals to identify a subgroup of patients with high risk of relapse who could potentially benefit from more intensive adjuvant treatment.

Immunoscore® evaluates the immune contexture of the tumor by quantifying CD3+ and CD8+ T-cells infiltrates both in the core of the tumor and in its invasive margin (Hermitte F, 2016), which has been shown to have a significant prognostic value in several cancers. Immunoscore® Colon was demonstrated to improve prognostic accuracy independently of clinical variables for all patients with Colon Cancer stages I-III and to have superior prognostic power versus the classical TNM staging system (Galon J, 2006; Mlecnik B, 2011). It was also demonstrated to have a superior predictive value than Microsatellite instability with respect to patients’ disease-specific recurrence and survival (Mlecnik B, 2016). These results have been confirmed in the Immunoscore® worldwide consortium multicentric study, including more than 3,800 stage I-III colon cancer patients, led by the Society for Immunotherapy of Cancer (SITC) (Galon J, 2016 (A); Galon J, 2016 (B)).

In 2016, HalioDx initiated retro-prospective clinical studies on several hundreds of patients’ samples from randomized clinical trials. The results expected in 2017 and 2018 will increase the Immunoscore® Colon level of evidence, support its integration in routine practice and its expanded access thanks to a dedicated reimbursement.

Immunoscore® Colon is available since July 2016 through HalioDx service laboratory. More than 850 tests have already been performed by HalioDx. Immunoscore® Colon CE-IVD test is now available as a full service or through the Immunoscore® Colon CE-IVD kit. The image analysis, critical to the robustness of the results is in all cases provided by HalioDx.  

Vincent FERT, CEO of HalioDx comments “The commercial availability of Immunoscore® for guiding treatment options in colon cancer is indeed an important critical milestone for HalioDx. It is also a landmark event in the era of immuno-oncology, for patients, caregivers and industry as Immunoscore® is the first test enabling a robust and precise assessment of the patient’s immune response to cancer. We envision that Immunoscore® is going to be a standard in cancer diagnostic and will expand its utility to many other cancers”. 

He added:  “We are in line with our timelines for launching our first CE-IVD test and are pursuing our efforts to develop and make available other breakthrough immune diagnostic solutions for unmet medical needs.”