The Current Policy Debate around the Regulation of LDTs: What It Means for Infectious Disease Testing and Where It May Be Headed

Abstract

The debate over federal regulation of diagnostic tests is not new, but scientific advances, societal developments, and global events over the past decade have accelerated efforts by the Food and Drug Administration (FDA) and members of Congress to revise the regulatory oversight of these devices, including laboratory-developed tests (LDTs). Despite years of congressional hearings and public meetings, legislation in the House and Senate, draft guidance from the FDA, and debate in the stakeholder community, LDT regulation remains unchanged, and the path forward remains unclear. LDTs play an essential role in infectious disease (ID) management and treatment, and changes in their regulation will have far-reaching implications for diagnostic laboratories. LDTs are widely used by clinical microbiology laboratories for the diagnosis and monitoring of a myriad infectious diseases, and until three years ago, such testing was conducted largely out of the spotlight. The COVID-19 pandemic changed this by bringing ID tests into the forefront. As the 118th Congress gets under way, the regulation and oversight of diagnostic tests, including LDTs, remains at the forefront of health care policy discussions on Capitol Hill and with the FDA. Change is coming, and it is important that clinical microbiologists, ID physicians, and other laboratorians have a seat at the table when such changes are being discussed.