Auria is a lab-developed test (LDT) that has been validated in Namida Lab’s high-complexity Clinical Laboratory Improvement Amendments (CLIA) lab under the supervision of our Medical Director.
An LDT is a test that is designed, developed, and performed within a single laboratory, regulated by the Centers for Medicare & Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). Currently, the FDA exercises enforcement discretion over LDTs. Certification of the laboratory is required under CLIA to ensure the validity and quality of the test.