title: FDA regulation of laboratory-developed tests.
authors.affiliation: Foundation Medicine, Cambridge, Massachusetts.
authors.forename: Vincent A
authors.initials: VA
authors.lastname: Miller
mesh_terms: D019937:Diagnostic Techniques and Procedures / Q000592:standards; D006801:Humans; D007753:Laboratories; D008495:Medical Oncology; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence