Caris Life Sciences® (NASDAQ:CAI), a leading patient-centric next-generation AI TechBio company and precision medicine pioneer, today announced that it has submitted an application to the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP), administered through the Wadsworth Center, seeking authorization to perform Caris Assure®, its blood‑based molecular profiling test, on specimens originating from New York State.

Caris Assure is a blood‑based molecular profiling test designed to support comprehensive biomarker analysis using a minimally invasive blood sample. Caris Assure uses circulating nucleic acids sequencing (cNAS) to analyze the whole exome (DNA) and whole transcriptome (RNA) of 22,000 genes. This comprehensive test identifies tumor alterations, clonal hematopoiesis (CH) and inherited variants, pharmacogenomic alterations, microsatellite instability (MSI) and tumor mutational burden (TMB).

The submission initiates the formal review process required by New York State for clinical laboratories seeking to perform testing on specimens collected from New York patients. Through the Wadsworth Center, CLEP conducts comprehensive reviews of laboratory permits and laboratory-developed tests to evaluate analytical validation, quality systems, personnel qualifications and compliance with applicable state regulations.

At this time, no determination has been made by NYSDOH, and Caris Assure is not authorized for use on blood-based specimens originating from New York State unless and until CLEP authorization is granted.

Caris operates a CAP-accredited, CLIA‑certified clinical laboratory and performs testing in jurisdictions where it is authorized to do so, in accordance with all applicable federal, state, and local regulations. Any future availability of Caris Assure in New York State will be contingent upon completion of the CLEP review process administered by the Wadsworth Center and receipt of the appropriate authorization.