• Angela M Caliendo, Marc R Couturier, Christine C Ginocchio, Kimberly E Hanson, Melissa B Miller, Kimberly E Walker, Gregory M Frank, and Infectious Diseases Society of America; the American Society for Microbiology; and the Pan-American Society for Clinical Virology.
• Department of Medicine, Alpert Medical School of Brown University, Providence, Rhode Island.
• Clin. Infect. Dis. 2016 Jul 15; 63 (2): 151-4.

AbstractIn 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.© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

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