Caris Life Sciences submitted an application to the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program for authorization to run its Caris Assure blood-based genomic profiling assay. The review process will be conducted by the Wadsworth Center. Caris Assure uses circulating nucleic acids sequencing to analyze whole-exome and whole-transcriptome coverage across 22,000 genes. Caris said the assay can identify tumor alterations, clonal hematopoiesis, inherited variants, pharmacogenomic alterations, microsatellite instability, and tumor mutational burden. The submission is strategically significant because molecular profiling services have been a major revenue driver for Caris, with the company citing that Caris Assure and related offerings contributed to a 125% year-over-year revenue increase in Q4 and a 79% lift in Q1. Operationally, expanding state authorization reduces friction for health systems and supports broader commercial uptake of liquid profiling in oncology.
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