Auria is a CLIA-certified validated laboratory-developed test and is overseen by CLIA. The American Association for Clinical Chemistry recommends that CLIA remain the primary mechanism for overseeing clinical laboratories. The Association supports modernizing the laboratory standard to ensure that it continues to meet the changing needs of the healthcare community. Revisions to the regulations should particularly address the laboratory inspection process, quality control recommendations, proficiency testing requirements, and the definition of what constitutes an LDT. Current CLIA requirements are as follows: The Food and Drug Administration (FDA) defines an LDT as an “in vitro diagnostic test that is manufactured and used within a single laboratory” (1). CMS accepts this definition (2).
In addition, the agency considers any modification to an FDA-cleared or approved assay as the creation of a new test and therefore an LDT. All LDTs are classified as high-complexity tests, the most stringent category of testing under CLIA. Laboratories performing such testing must comply with rigorous quality control (QC), proficiency testing (PT), and personnel requirements and must demonstrate the test’s analytical validity. Although CLIA does not require clinical laboratories to establish clinical validity1, the major private sector accrediting organizations to which many laboratories conducting LDTs subscribe, such as the College of American Pathologists (CAP) and the Joint Commission, do require that laboratories document clinical validation.