Journal:The regulatory landscape of precision oncology laboratory medicine in the United States: Perspective on the past five years and considerations for future regulation
| Full article title |
The regulatory landscape of precision oncology laboratory medicine in the United States: Perspective on the past five years and considerations for future regulation |
|---|---|
| Journal | Practical Laboratory Medicine |
| Author(s) | Konnick, Eric Q. |
| Author affiliation(s) | University of Washington |
| Primary contact | Email: konnick at uw dot edu |
| Year published | 2020 |
| Volume and issue | 21 |
| Article # | e00172 |
| DOI | 10.1016/j.plabm.2020.e00172 |
| ISSN | 2352-5517 |
| Distribution license | Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International |
| Website | https://www.sciencedirect.com/science/article/pii/S2352551719301040 |
| Download | https://www.sciencedirect.com/science/article/pii/S2352551719301040/pdfft (PDF) |
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This article should be considered a work in progress and incomplete. Consider this article incomplete until this notice is removed. |
Abstract
The regulatory landscape for precision oncology in the United States is complicated, with multiple governmental regulatory agencies with different scopes of jurisdiction. Several regulatory proposals have been introduced since the Food and Drug Administration released draft guidance to regulate laboratory developed tests in 2014. Key aspects of the most recent proposals and discussion of central arguments related to the regulation of precision oncology laboratory tests provides insight to stakeholders for future discussions related to regulation of laboratory tests.
Keywords: oncology, regulation, testing, LDTs, FDA, CLIA, CMS
The current regulatory environment in the United States
References
Notes
This presentation is faithful to the original, with only a few minor changes to presentation. Some grammar and punctuation was cleaned up to improve readability. Otherwise, in accordance with the NoDerivatives portion of the original license, nothing else has been changed.
