Caris Life Sciences filed an application with the New York State Department of Health for authorization to run its Caris Assure blood-based genomic profiling assay on specimens from New York. The review will be conducted through NYSDOH’s Clinical Laboratory Evaluation Program, with the Wadsworth Center administering the evaluation. Caris Assure is described as a circulating nucleic acid sequencing test enabling whole-exome and whole-transcriptome analysis across 22,000 genes. The assay is positioned to support tumor alterations, clonal hematopoiesis, inherited variants, pharmacogenomic alterations, microsatellite instability, and tumor mutational burden assessment. Caris said expanding access to Assure is a growth driver and referenced revenue contribution from its molecular profiling services. For labs and oncology programs, state authorization can determine whether testing networks can scale locally and whether turnaround and compliance requirements align with institutional workflows.
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