Authors’ Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the author disclosure form. Disclosures and/or potential conflicts of interest: Employment or Leadership: P.M. Jones, AACC Policy and External Affairs Core Committee chair and Clinical Biochemistry associate editor; D.J. Dietzen, The Journal of Applied Laboratory Medicine, AACC; A.N. Hoofnagle, Clinical Chemistry, AACC; C.M. Lockwood, Association of Molecular Pathology, chair of liquid biopsy working group, and spouse employed by Bayer; E.Q. Konnick, College of American Pathologists, chair of Genomic Medicine Committee, Association of Molecular Pathology board of directors, Association of Molecular Pathology, chair of Professional Relations Committee, and Washington State Society of Pathologists vice president. Consultant or Advisory Role: D.J. Dietzen, Roche Diagnostics Point of Care, Danaher, Becton-Dickinson, and Waters consulting. Stock Ownership: None declared. Honoraria: None declared. Research Funding: D.J. Dietzen, Abbott Diagnostics and Roche Diagnostics contract/grants; A.N. Hoofnagle, NIH and Waters, Inc. grants/contracts. Expert Testimony: D.J. Dietzen, Federal Court—Eastern District of Missouri expert witness; A.N. Hoofnagle, Kilpatrick Townsend & Stockton LLP expert witness. Patents: None declared. Other Remuneration: P.M. Jones, Elsevier, McGraw Hill royalties; D.J. Dietzen, Elsevier, McGraw Hill royalties.