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Caris Life Sciences, a leading patient-centric next-generation AI TechBio company and precision medicine pioneer, announced that it has submitted an application to the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Programme (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 tumour alterations, clonal hematopoiesis (CH) and inherited variants, pharmacogenomic alterations, microsatellite instability (MSI) and tumour 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.
“Caris is committed to meeting the highest standards for laboratory quality, validation and regulatory compliance,” said David Spetzler, MS, PhD, MBA, president of Caris Life Sciences. “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 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.
Caris Life Sciences (Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Genome, Whole Exome and Whole Transcriptome Sequencing), advanced AI and machine learning, Caris has created the large-scale, multimodal clinico-genomic database and computing capability needed to analyze and further unravel the molecular complexity of disease.
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