AMP Open to Expanded Regulation of LDTs Under CLIA Umbrella

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 paper. “This professional service yields the final information that can be applied by direct caregivers to establish a patient’s diagnosis, estimate his/her prognosis, and identify optimal, appropriate, and/or potential treatment options, and more. . . . LDTs require a regulatory pathway that acknowledges these differences from medical devices and preserves the role of the laboratory professional.” As such, AMP reaffirmed “that the CLIA program, in combination with laboratory accreditation programs and professional certification, provides a rigorous and flexible framework for ensuring high quality laboratory testing in the United States,” said Elaine Lyon, Ph.D., AMP president, in a statement. “The current regulatory oversight system enables pathologists and other laboratory professionals to rapidly incorporate new findings into practice, and to modify existing laboratory tests and their usage in accordance with advances in clinical knowledge. This has allowed timely and appropriate introduction of innovative testing into practice, and it has also helped foster patient access to the most up-to-date treatment options.” However, AMP recognizes that there are three areas where expanded regulation under the CLIA umbrella may be appropriate. These include:

• Verification of LDP’s clinical validity, such that a clinical consultant reviews the appropriateness of testing ordered and interpretation of test results.

• Increased transparency by making public the CLIA registry of laboratories and their test offerings, including making public information about adverse events and other significant problems that have occurred within a laboratory.

• Requring preintroduction review by a third-party reviewer for exceptionally high-risk LDPs, including those for which methods or determinants of results (black box algorithms or proprietary software) lack transparency, or assays for which a skilled laboratory professional cannot independently interpret or assess the validation of the test or its results.

Takeaway: The CLIA umbrella remains the preferred means of enhancing regulation of LDTs, says AMP, which also believes that the professional service component LDTs needs to be more formally recognized as a differentiator between LDTs and traditional medical devices.