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Illumina said this week that the US Food and Drug Administration has granted it breakthrough device designation for its pan-cancer assay, which is currently in development. Illumina plans to market the assay as TruSight Oncology Comprehensive. It will be based on the content of the firm's TruSight Oncology 500 (TSO 500) assay, which is designed to detect known and emerging biomarkers for solid tumors. Illumina is seeking FDA approval for the assay as a companion diagnostic.

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