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How New Regulation of Laboratory-Developed Antimicrobial Susceptibility Tests Will Affect Infectious Diseases
Kaleb H Wolfe1, Virginia M Pierce2, Romney M Humphries3
1Department of Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee.
Abstract:
Antimicrobial resistance (AMR) affects 2.8 million Americans annually. AMR is identified through antimicrobial susceptibility testing (AST), but current and proposed regulatory policies from the United States Food and Drug Administration (FDA) jeopardize the future availability of AST for many microorganisms. Devices that perform AST must be cleared by the FDA using their susceptibility test interpretive criteria, also known as breakpoints. The FDA list of breakpoints is relatively short. Today, laboratories supplement FDA breakpoints using breakpoints published by the Clinical and Laboratory Standards Institute, using legacy devices and laboratory-developed tests (LDTs). FDA proposes to regulate LDTs, and with no FDA breakpoints for many drug-bug combinations, the risk is loss of AST for key clinical indications and stifling innovation in technology development. Effective solutions require collaboration between manufacturers, infectious diseases clinicians, pharmacists, laboratories, and the FDA.
Insights
Antimicrobial resistance (AMR) impacts millions yearly. Proposed Food and Drug Administration (FDA) regulations may limit antimicrobial susceptibility testing (AST), risking patient care and innovation.
Area of Science:
- Clinical microbiology
- Infectious diseases
- Regulatory science
Background:
- Antimicrobial resistance (AMR) poses a significant public health threat, affecting millions annually in the US.
- Antimicrobial susceptibility testing (AST) is crucial for diagnosing and treating bacterial infections.
- Current and proposed FDA regulatory policies may restrict the availability of AST for various microorganisms.
Purpose of the Study:
- To analyze the impact of FDA regulatory policies on the future availability of antimicrobial susceptibility testing (AST).
- To highlight the risks associated with proposed regulations on laboratory-developed tests (LDTs) and technological innovation in AST.
Main Methods:
- Review of current FDA regulations and proposed policies concerning AST devices and breakpoints.
- Analysis of the reliance on Clinical and Laboratory Standards Institute (CLSI) breakpoints and laboratory-developed tests (LDTs) to supplement FDA data.
- Examination of the potential consequences of regulating LDTs without comprehensive FDA-established breakpoints.
Main Results:
- The FDA's limited list of susceptibility test interpretive criteria (breakpoints) necessitates reliance on external sources like CLSI.
- Proposed FDA regulation of LDTs, coupled with a lack of FDA breakpoints for many drug-bug combinations, threatens the continuity of AST.
- This regulatory landscape risks limiting critical clinical diagnostic capabilities and hindering advancements in AST technology.
Conclusions:
- Effective solutions to preserve AST availability require collaborative efforts among manufacturers, clinicians, pharmacists, laboratories, and the FDA.
- Addressing the regulatory gaps in AST is essential to combat antimicrobial resistance and ensure optimal patient care.
- Proactive engagement and policy refinement are necessary to foster innovation and maintain robust diagnostic testing capabilities.
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