Biodesix is a CAP Accredited clinical laboratory regulated by the Centers for Medicare & Medicaid Services (CMS) pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988. In addition to holding a CLIA certificate of Accreditation by College of American Pathologists (CAP), Biodesix QMS complies with and maintains a certification with ISO 13485, a harmonized international standard for quality management systems. Biodesix has received approval from New York State Department of Health, Clinical Laboratory Standards of Practice (NYS CLEP) in Soluble Tumor Markers and Molecular, Cellular Tumor Markers as well as complying with all applicable regulatory and state agency requirements holding state permits and licenses in California, Florida, Maryland, New York, Pennsylvania, and Rhode Island.

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