Modernizing Federal Oversight of Laboratory-Developed Tests - Toward Safety, Validity, and Utility

Affiliation

• ¹ From the Department of Urology, Rogel Cancer Center, University of Michigan, Ann Arbor (U.S., T.M.M.); the Department of Urology, Mayo Clinic, Rochester, MN (U.S.); and the Program on Regulation, Therapeutics, and Law, Brigham and Women's Hospital and Harvard Medical School, Boston (C.H., A.S.K.).