Maintaining Life-saving Testing for Patients With Infectious Diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests.
In 2014, the US Food and Drug Administration (FDA) proposed to regulate laboratory-developed tests (LDTs)-diagnostics designed, manufactured, and used within a single laboratory. The Infectious Diseases Society of America, the American Society for Microbiology, and the Pan American Society for Clinical Virology recognize that the FDA is committed to protecting patients. However, our societies are concerned that the proposed regulations will limit access to testing and negatively impact infectious diseases (ID) LDTs. In this joint commentary, our societies discuss why LDTs are critical for ID patient care, hospital infection control, and public health responses. We also highlight how the FDA's proposed regulation of LDTs could impair patient access to life-saving tests and stifle innovation in ID diagnostics. Finally, our societies make specific recommendations for the FDA's consideration to reduce the burden of the proposed new rules on clinical laboratories and protect patients' access to state-of-the art, quality LDTs.
Department of Medicine, Alpert Medical School of Brown University, Providence, Rhode Island.
Angela M
AM
Caliendo
Department of Pathology, University of Utah ARUP Laboratories, Salt Lake City.
Marc R
MR
Couturier
Hofstra North Shore-LIJ School of Medicine, Hempstead, New York bioMérieux, Durham, North Carolina BioFire Dx.
Christine C
CC
Ginocchio
University of Utah Departments of Medicine and Pathology, Divisions of Infectious Diseases and Clinical Microbiology, Salt Lake City.
Kimberly E
KE
Hanson
Clinical Molecular Microbiology Laboratory, UNC Health Care Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill.
Melissa B
MB
Miller
American Society for Microbiology, Washington D.C.
Kimberly E
KE
Walker
Infectious Diseases Society of America, Arlington, Virginia.
Gregory M
GM
Frank
D003141:Communicable Diseases / Q000175:diagnosis*; D003955:Diagnostic Tests, Routine; D006287:Health Planning Guidelines; D006297:Health Services Accessibility; D006801:Humans; D007753:Laboratories / Q000331:legislation & jurisprudence*; D011050:Policy Making; D012955:Societies, Medical; D014481:United States; D014486:United States Food and Drug Administration
FDA; LDT; diagnostics; infectious diseases; laboratory-developed tests