IRVING, Texas, May 8, 2026
Caris Life Sciences® has submitted an application to the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) seeking authorization for its Caris Assure® blood-based molecular profiling test to process specimens originating from New York State. The move marks a significant regulatory milestone for the precision medicine company as it continues expanding access to advanced liquid biopsy and molecular diagnostics technologies across the United States. The submission was made through the Wadsworth Center, which oversees laboratory-developed test reviews and clinical laboratory compliance in New York.
Caris Assure Aims to Advance Blood-Based Precision Oncology
Caris Assure® is designed as a minimally invasive blood-based molecular profiling test capable of delivering broad genomic insights through circulating nucleic acids sequencing (cNAS). The platform analyzes both the whole exome (DNA) and whole transcriptome (RNA) of approximately 22,000 genes, providing oncologists and researchers with extensive biomarker data to support precision medicine decisions.
The test is engineered to detect a wide range of clinically relevant genomic features, including tumor alterations, microsatellite instability (MSI), tumor mutational burden (TMB), pharmacogenomic variants, inherited mutations and clonal hematopoiesis (CH). By using a blood sample instead of traditional tissue biopsies, Caris Assure aims to improve accessibility to molecular testing for cancer patients while supporting faster and less invasive genomic profiling workflows.
The test is engineered to detect a wide range of clinically relevant genomic features, including tumor alterations, microsatellite instability (MSI), tumor mutational burden (TMB), pharmacogenomic variants, inherited mutations and clonal hematopoiesis (CH). By using a blood sample instead of traditional tissue biopsies, Caris Assure aims to improve accessibility to molecular testing for cancer patients while supporting faster and less invasive genomic profiling workflows.
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Regulatory Review Highlights Compliance and Laboratory Standards
According to David Spetzler, MS, PhD, MBA, President of Caris Life Sciences, the application reflects the company’s commitment to maintaining high laboratory and regulatory standards while responsibly expanding access to precision oncology technologies. He emphasized that the submission demonstrates Caris’ focus on quality, scientific rigor, patient-centered innovation and regulatory compliance in every market where the company operates.
Caris also clarified that Caris Assure is not currently authorized for use on blood-based specimens originating from New York State until CLEP approval is granted. The company operates a CAP-accredited and CLIA-certified clinical laboratory, performing testing only in jurisdictions where authorization has been obtained under applicable federal and state regulations.
The company noted that any future commercialization or availability of Caris Assure in New York will remain dependent on successful completion of the Wadsworth Center review process and receipt of the necessary approvals from NYSDOH authorities.
AI-Driven Precision Medicine Expansion Continues
Headquartered in Irving, Texas, Caris Life Sciences has positioned itself as a leading AI-driven precision medicine and molecular diagnostics company. The organization combines next-generation sequencing, artificial intelligence, machine learning and large-scale clinico-genomic databases to support advanced cancer profiling, therapy selection, disease monitoring and drug development initiatives.
Caris continues investing heavily in technologies that integrate genomic data with computational analytics to accelerate personalized medicine strategies. The company’s platform supports applications in early detection, diagnosis, monitoring and treatment optimization, making liquid biopsy technologies increasingly important in oncology care pathways.
Industry observers view the NYSDOH submission as part of a broader trend toward expanding adoption of blood-based genomic profiling tests capable of delivering comprehensive cancer insights with reduced procedural burden for patients. As demand for precision oncology solutions grows, regulatory clearances in highly regulated states such as New York may further strengthen commercial positioning and clinical adoption opportunities for companies operating in the molecular diagnostics sector.
Source: Caris Life Sciences press release
