title: Regulating laboratory-developed tests: devil will be in details.
authors.forename: Caroline
authors.initials: C
authors.lastname: McNeil
mesh_terms: D019411:Clinical Laboratory Techniques / Q000379:methods / Q000592:standards / Q000639:trends; D006801:Humans; D009369:Neoplasms / Q000175:diagnosis / Q000235:genetics; D057285:Precision Medicine; D015203:Reproducibility of Results; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration