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HalioDx Lab Achieves CLIA Compliance

NEW YORK (360Dx) – French immune-oncology diagnostics firm HalioDx today announced its full-service reference laboratory in Marseille, France is CLIA compliant, which allows the firm to receive patient samples from the US for testing with the Immunoscore Colon test.

The test is being offered to oncologists and pathologists taking care of colon cancer patients in certain states in the US. According to the Immunoscore website, the test cannot be performed on patient samples originating from California, Florida, Georgia, Kentucky, Maryland, Nevada, New York, Pennsylvania, Rhode Island, and Tennessee.

Immunoscore is an immunohistochemistry assay enhance by image analysis, and is used to quantify the immune infiltration in patients' tumors that guides treatment at the time of diagnosis, HalioDx said. The assay is performed on formalin-fixed, paraffin-free samples and has a turnaround time of 10 days.

It is available also for research use only and as a CE-IVD device in countries that recognize the designation.

HalioDx was created in 2015 following a buyout by Qiagen Marseille's former executive management team.