ASM Statement in Response to Health Subcommittee Hearing

March 19, 2024

Statement from the American Society for Microbiology in response to the
Energy and Commerce Health Subcommittee Hearing:
“Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule”

Hearing Date: March 21, 2024

On behalf of our 36,000 members, the American Society for Microbiology (ASM) commends Chairman Guthrie, Ranking Member Eshoo and members of the Energy and Commerce Subcommittee on Health for holding a hearing on the Food and Drug Administration’s (FDA) proposed rule to regulate laboratory-developed tests. ASM submitted comments on the proposed rule in Dec. 2023.

ASM remains concerned that the FDA’s proposed rule will reduce patient access to high quality and timely infectious disease testing, increase health inequities and limit innovation in developing new LDTs for infectious disease testing. The broad approach taken by FDA doesn’t recognize the unique aspects of infectious disease testing, applying standards that will result in the opposite of what FDA seeks to achieve. 

ASM members perform testing for the diagnosis of infectious diseases in clinical, commercial and public health laboratories in a range of urban and rural settings. A fall 2023 survey of ASM members showed that laboratory-developed tests (LDTs) are widely used in clinical and public health laboratories for the diagnosis and monitoring of myriad infectious diseases.  

LDTs have been at the forefront of clinical innovation in the detection and management of infectious diseases. In many instances, including the 2022 mpox outbreak, LDTs were the first available tests for emerging infectious diseases and were central to the outbreak response. According to the recent ASM survey, 42% of laboratories reported performing more than 10 LDTs. The investment in personnel, time and resources required to obtain FDA approval for existing LDTs will halt the development of novel diagnostics, hindering the innovation and diagnostic progress necessary to keep up with emerging and evolving pathogens.

ASM shares the FDA’s goal of protecting public health and ensuring the safety and accuracy of LDTs and health equity. We recognize that there is a lack of information on the current LDTs on the market. To address this, ASM supports registration and listing requirements and severe adverse event reporting for LDTs as a first step toward collecting necessary data and developing a regulatory path for LDTs that is consistent with the realities of how these tests are used in infectious disease care. ASM also supports a risk-based framework, where a low-risk category with enforcement discretion will allow clinical microbiology laboratories to continue with most infectious disease LDTs to serve the most vulnerable communities and serve as sentinel laboratories to local and state public health entities in public health emergencies.  

After collecting data and attaining a more accurate and comprehensive picture of the LDT landscape, ASM believes that the FDA, in conjunction with stakeholders and the public, will be better able to determine a more effective approach to regulation of these tests than that outlined in the proposed rule. With knowledge of the universe of LDTs and their applications, as well as more robust adverse event reporting, we believe a risk-based approach that maintains enforcement discretion for low-risk tests will be feasible.

ASM again appreciates the Health Subcommittee’s focus on the appropriate regulatory framework for diagnostics, including LDTs. We urge Congress to revive discussions with the goal of finding a path forward that is not one-size-fits-all and considers the realities of how LDTs are used in medical specialties like infectious disease, and we look forward to working with the committee on this important issue.

The American Society for Microbiology is one of the largest professional societies dedicated to the life sciences and is composed of 36,000 scientists and health practitioners. ASM's mission is to promote and advance the microbial sciences.

ASM advances the microbial sciences through conferences, publications, certifications, educational opportunities and advocacy efforts. It enhances laboratory capacity around the globe through training and resources. It provides a network for scientists in academia, industry and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences.
ASM released an updated statement in response to the Food and Drug Administration's final rule on laboratory-developed tests.

Author: ASM Advocacy

ASM Advocacy
ASM Advocacy is making it easy and providing opportunities for members to advocate for evidence-based scientific policy.