Counterpoint: Why the FDA Should Not Regulate Laboratory-Developed Tests
Author:
Affiliation:
1. The Steve and Cindy Rasmussen Institute for Genomic Medicine, Nationwide Children’s Hospital , Columbus, OH , United States
2. Departments of Pathology and Pediatrics, The Ohio State University College of Medicine , Columbus, OH , United States
Publisher
Oxford University Press (OUP)
Link
https://academic.oup.com/jalm/article-pdf/9/1/155/54973769/jfad085.pdf
Reference11 articles.
1. Laboratory-developed tests: a legislative and regulatory review;Genzen;Clin Chem,2017
2. Comparison of laboratory-developed tests and FDA-approved assays for BRAF, EGFR, and KRAS testing;Kim;JAMA Oncol,2018
3. FDA Guidance for next generation sequencing-based testing: balancing regulation and innovation in precision medicine;Luh;NPJ Genom Med,2018
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