PR Newswire·May 8, 2026, 4:05 PM ET

Caris Life Sciences Submits Application to New York State Department of Health for Caris Assure Blood‑Based Testing Authorization

Caris Life Sciences submitted an application to the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) for authorization to perform its Caris Assure® blood-based molecular profiling test on specimens from New York State.
The CLEP review process, administered through the Wadsworth Center, evaluates analytical validation, quality systems, personnel qualifications, & regulatory compliance.
Caris Assure utilizes circulating nucleic acids sequencing (cNAS) to analyze the whole exome (DNA) & whole transcriptome (RNA) of 22,000 genes for tumor alterations, clonal hematopoiesis, inherited variants, pharmacogenomic alterations, microsatellite instability (MSI), & tumor mutational burden (TMB).
No determination has been made by the NYSDOH, & Caris Assure is not currently authorized for use on New York blood specimens pending successful completion of the CLEP review.
Future availability of Caris Assure in New York State is contingent upon receiving appropriate authorization from the CLEP.
Caris operates a CAP-accredited, CLIA-certified laboratory & conducts testing only in jurisdictions where authorized by applicable federal, state, & local regulations.