FDA and CLIA oversight of advanced diagnostics and biomarker tests.
Terry
Sharon F
SF
Genetic Alliance, 4301 Connecticut Avenue, NW Suite 404, Washington, DC 20008, USA. sterry@geneticalliance.org
D015415:Biomarkers / Q000032:analysis*; D001943:Breast Neoplasms / Q000175:diagnosis; D019411:Clinical Laboratory Techniques / Q000592:standards*; D003951:Diagnostic Errors / Q000517:prevention & control; D005260:Female; D005820:Genetic Testing / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D006801:Humans; D007753:Laboratories / Q000592:standards; D007883:Legislation, Medical; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods / Q000592:standards; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
D015415:Biomarkers; D011933:Reagent Kits, Diagnostic