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Revisiting oversight and regulation of molecular-based laboratory-developed tests: a position statement of the
Andrea Ferreira-Gonzalez1, Rajyasree Emmadi2, Stephen P Day3
1The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Division of Molecular Diagnostics, Department of Pathology, Virginia Commonwealth University, Richmond, Virginia.
Abstract:
Since 2006, the US Food and Drug Administration, Congress, and other policymakers have explored the appropriate way to guarantee the clinical and analytical validity of laboratory-developed tests. In the past, the Association for Molecular Pathology has publicly urged the Food and Drug Administration to exercise caution in implementing regulatory changes that could potentially hinder innovation or interfere with the practice of medicine. In 2012, the Association for Molecular Pathology Professional Relations Committee chose to develop this paper with the goal of outlining the best methods for ensuring appropriate oversight and validation of molecular diagnostic procedures. At the conclusion of this process, the workgroup reaffirmed the Association's previous position that the Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments program can provide the appropriate level of oversight for the vast majority of diagnostic tests.
Insights
The Association for Molecular Pathology recommends that the Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments program can adequately oversee most laboratory-developed tests, ensuring their validity without hindering innovation.
Area of Science:
- Clinical diagnostics
- Molecular pathology
- Regulatory science
Background:
- Policymakers have debated regulating laboratory-developed tests (LDTs) since 2006.
- The Association for Molecular Pathology (AMP) has previously cautioned against regulations that could stifle innovation.
- The AMP Professional Relations Committee aimed to define optimal oversight for molecular diagnostics.
Purpose of the Study:
- To outline best practices for the validation and oversight of molecular diagnostic procedures.
- To address the regulatory landscape for laboratory-developed tests.
- To reaffirm the AMP's stance on LDT regulation.
Main Methods:
- Review of existing regulatory frameworks.
- Expert consensus development within the AMP Professional Relations Committee.
- Analysis of the Clinical Laboratory Improvement Amendments (CLIA) program's capabilities.
Main Results:
- The CLIA program provides sufficient oversight for most diagnostic tests.
- Proposed regulatory changes by the Food and Drug Administration (FDA) may pose risks to innovation.
- The AMP's position supports existing CLIA oversight for LDTs.
Conclusions:
- The Centers for Medicare and Medicaid Services' CLIA program is adequate for overseeing the majority of diagnostic tests.
- The AMP advocates for a cautious approach to new FDA regulations on LDTs.
- Maintaining the current CLIA framework ensures both test validity and medical innovation.
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