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 in-state. The review will be conducted by NYSDOH’s Wadsworth Center, starting a formal evaluation process for the blood-based genomic profiling assay. Caris Assure is described as a circulating nucleic acids sequencing test that analyzes whole-exome and whole-transcriptome features across 22,000 genes, covering tumor alterations, inherited variants, pharmacogenomic markers, and tumor mutational burden. Caris said the Assure submission aligns with its strategy to expand technology access while emphasizing laboratory quality and regulatory compliance.
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