Caris Life Sciences submits application to NYSDOH for Caris Assure testing

Caris Life Sciences (CAI) announced that it has submitted an application to the New York State Department of Health Clinical Laboratory Evaluation Program, administered through the Wadsworth Center, seeking authorization to perform Caris Assure, its blood-based molecular profiling test, on specimens originating from New York State. 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.