NEW YORK (360Dx) – HalioDx today announced its Immunoscore Colon assay has received CE-IVD marking.
The assay is designed to help clinicians assess the prognosis of primary colon cancer, in combination with the TNM classification and other clinical and biological features. The test evaluates the immune contexture of a patient's colon tumor and determines the likelihood that the cancer will spread, as well as the likelihood that the disease will recur after surgery, HalioDx said.
Immunoscore Colon quantifies CD3+ and CD8+ cell infiltrates in the core tumor and in its invasive margin. HalioDx initiated retro-prospective clinical studies on several hundred patient samples from randomized clinical trials in 2016. Additional results this year and in 2018 are expected to increase the level of evidence in favor of the test, support its integration in routine practice, and support its anticipated access through payor reimbursements, said the France-based firm, which was spun out from a Qiagen business.
Immunoscore Colon was launched during the summer through HalioDx's laboratory. With CE-IVD marking, it is now available as a full-service or as a kit in Europe. The kit is intended for in vitro diagnostic use in Europe and is available for research-use only in the rest of the world.