The Clinical Laboratory Improvement Amendments (CLIA) program remains the appropriate source for oversight for the vast majority of diagnostic laboratory-developed tests (LDTs), but the Association for Molecular Pathology (AMP) is open to some additional oversight under the CLIA umbrella, according to a position statement published in the January issue of the Journal of Molecular Diagnostics. CLIA oversight, the organization says, preserves flexibility and innovation that might be lost if the U.S. Food and Drug Administration regulated LDTs as traditional medical devices and CLIA also appropriately recognizes the professional services component that AMP says provides critical value to LDTs. In recognition of the continuous supervision that trained professionals have over the development, validation, and interpretation of complex LDTs, AMP proposes the term laboratory-developed procedure (LDP) to distinguish LDTs from traditional medical devices. They define an LDP as a “professional service that encompasses and integrates the design, development, validation, verification, and quality systems used in laboratory testing, and interpretative reporting in the context of clinical care.” “Molecular testing continues to rapidly increase in complexity, generating ever-increasing amounts of potentially useful data. In turn, this enhances the complexity and value of the interpretive component,” writes the AMP’s Professional Relations Committee, which authored the […]