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HalioDx receives CLIA Compliance for Immunoscore® Colon

• HalioDx received CMS CLIA Compliance for its laboratory based in Marseille

• Immunoscore® Colon, is now available to US patients in selected states with a turnaround time of 10 days

 

·         HalioDx received CMS[1] CLIA Compliance for its laboratory based in Marseille

·         Immunoscore® Colon, is now available to US patients in selected states with a turnaround time of 10 days

 

HalioDx announced today that the company is compliant under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its Marseille-based full service Reference Laboratory. This compliance allows the company to receive US patient samples for Immunoscore® Colon testing.

As a CLIA compliant laboratory, the Immunoscore® Colon assay is performed on FFPE samples with a turnaround time of 10 days and is offered to oncologists and pathologists taking care of colon cancer patients in selected states in America (see Immunoscore® website). Immunoscore® Colon is available also as RUO and CE-IVD test in other countries.

Vincent FERT, CEO of HalioDx commentsThe availability of Immunoscore® Colon under CLIA compliance is indeed an important step for serving US patients and oncologists. We envision that Immunoscore® will set a new prognostic standard in guiding the treatment of colon cancer as the test value is now supported by strong clinical data presented at ASCO 2017. HalioDx plans to further reinforce clinical utility of Immunoscore® in colon cancer and also to expand to other types of cancer”. 

 


[1] Centers for Medicare & Medicaid Services.