Caris Life Sciences Seeks NY Authorization for Caris Assure Blood-Based Test
CAI•Caris Life Sciences has applied to the NY Department of Health’s Wadsworth Center for authorization of its Caris Assure blood-based profiling test on specimens from New York. It sequences the exome and transcriptome of 22,000 genes via cNAS to detect tumor alterations, clonal hematopoiesis, MSI and tumor mutational burden.
1. Regulatory Submission
On May 8, 2026 Caris Life Sciences submitted an application to the New York State Department of Health Clinical Laboratory Evaluation Program at the Wadsworth Center seeking authorization to perform its Caris Assure blood-based profiling test on specimens from New York patients.
2. Caris Assure Technology
Caris Assure uses circulating nucleic acids sequencing (cNAS) to analyze the whole exome and transcriptome across 22,000 genes. The test identifies tumor alterations, clonal hematopoiesis, inherited variants, pharmacogenomic changes, microsatellite instability and tumor mutational burden from a minimally invasive blood sample.
3. Review Process and Authorization Impact
The CLEP review will evaluate analytical validation, quality systems and personnel qualifications under state regulations. Caris must secure Wadsworth Center authorization before offering Caris Assure in New York, leveraging its existing CAP accreditation and CLIA certification for clinical operations.
