The application for the molecular profiling test initiates a review by the Wadsworth Center for specimens originating in New York.
Caris Life Sciences has submitted an application to the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) seeking authorization for its blood-based molecular profiling test, Caris Assure. The application, administered through the Wadsworth Center, is for testing performed on specimens originating from New York.
Caris Assure is a molecular profiling test designed for biomarker analysis using a minimally invasive blood sample. The technology uses circulating nucleic acids sequencing to analyze the whole exome and whole transcriptome of 22,000 genes. According to the company, the test identifies tumor alterations, clonal hematopoiesis, inherited variants, pharmacogenomic alterations, microsatellite instability, and tumor mutational burden.
The submission begins the formal review process required by the state for clinical laboratories. Through the Wadsworth Center, CLEP conducts reviews of laboratory permits and laboratory-developed tests to evaluate analytical validation, quality systems, personnel qualifications, and compliance with state regulations.
“Caris is committed to meeting the highest standards for laboratory quality, validation, and regulatory compliance,” says David Spetzler, president of Caris Life Sciences, in a release. “This submission of Caris Assure for review through the New York State Department of Health’s Wadsworth Center reflects our disciplined approach to expanding access to our technologies in a manner that demonstrates the rigor, responsibility, and focus on the patient that define Caris Life Sciences and guide our work in the markets we serve.”
At this time, no determination has been made by the New York State Department of Health. Caris Assure is not authorized for use on blood-based specimens originating from New York unless and until CLEP authorization is granted.
Caris operates a College of American Pathologists-accredited and Clinical Laboratory Improvement Amendments-certified clinical laboratory. The company performs testing in jurisdictions where it is authorized in accordance with federal, state, and local regulations. Any future availability of the test in New York will be contingent upon the completion of the review process and receipt of the appropriate authorization.
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