The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation
- The regulatory landscape for precision oncology in the United States is complex, involving multiple governmental agencies with varying jurisdictions.
- Since 2014, several regulatory proposals have been introduced following the FDA's draft guidance on laboratory-developed tests.
- There are ongoing discussions and proposals aimed at updating the regulatory environment for precision oncology laboratory tests.
- These discussions emphasize the need to balance the risks, benefits, and costs of different regulatory approaches.
- Evaluating the broader implications of test regulation is critical to ensure appropriate care for patients in challenging circumstances.
- Although many claims support the need for additional regulation, its impact on patient care and all stakeholders has not been fully assessed.
- Finding tools to enhance laboratory test quality can offer benefits without imposing a heavy regulatory burden.
The current state of laboratory test regulation in the United States (US) is complex and the prospect of changes in the current paradigm has been continually on the horizon since 2014. Briefly, clinical laboratories in the US are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 0 88)[1] of the Public Health Services Act, which are administered by the Center for Medicare and Medicaid Services (CMS). These regulations were put in place to improve the quality of the processes in clinical laboratories, but the regulations allow for organizations that have received certification from CMS to inspect laboratories as a deemed entity. This status allows deemed entities to place additional requirements in place, so long as the underlying CLIA requirements are met. CLIA regulations have a flexible framework that allows individual medical directors and laboratories to have some leeway in how the specific requirements are met, which allows for accommodation of unique population-, laboratory-, and test-level factors that can improve the overall quality of testing and allows for the development of tests by laboratory medicine practitioners within certain bounds. Testing kits that are manufactured and shipped across state lines are regulated by the United States (US) Food and Drug Administration (FDA) via the Medical Device Amendments of 1976 [2] to the Food, Drug, and Cosmetic Act of 1938. The FDA has several review and approval pathways where the manufacturer submits documentation and data to the FDA for review, and if the data fulfill the FDA’s requirements, the test receives marketing authorization. Manufacturers can then sell their products to laboratories, who wish to perform that testing. Testing kits which are cleared or approved by the FDA are regulated under CLIA when they are performed in a certified laboratory. In addition, under the current structure, laboratories are expected to verify the performance of these products and, under CLIA, are allowed to modify them if deemed necessary by medical leadership. If a manufactured product is modified by the user laboratory, the test is considered a laboratory developed test, and such modifications are frequently made to improve assay performance, use the assay in a way different from the use claimed by the manufacturer (e.g. diagnostic instead of screening applications), or allow acceptance of additional sample types that were not submitted to the FDA for approval....
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