Caris Life Sciences submitted an application to the New York State Department of Health’s Clinical Laboratory Evaluation Program for authorization to perform Caris Assure on specimens originating in New York. The formal review process will be conducted by the Wadsworth Center, marking another step in widening access to Caris’s blood-based genomic profiling. Caris Assure uses circulating nucleic acids sequencing to analyze whole-exome and whole-transcriptome data across 22,000 genes, with outputs spanning tumor alterations, pharmacogenomic markers, microsatellite instability, tumor mutational burden, and inherited variants. Caris said the submission reflects its approach to validation and regulatory compliance while expanding state-level availability of molecular profiling technology.
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