Proposed Food and Drug Administration (FDA) regulations on laboratory developed tests (LDTs) could have a disruptive impact on patient care and public health, and IDSA continues to educate policymakers about the important role of such tests and the potentially negative impact of the proposed regulations.
The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on LDTs earlier this month. In advance of that hearing, IDSA Diagnostics Task Force (DTF) Chair Angela Caliendo, MD, FIDSA, briefed the committee on how ID physicians use LDTs and how proposed regulations could severely limit patient access to testing and thwart innovation. IDSA also submitted formal testimony
(PDF) which furthered Dr. Caliendo’s points and offered alternative mechanisms for improving the oversight of LDTs while maintaining patient access to high quality testing and promoting innovation. The Senate HELP Committee Chairman, Senator Lamar Alexander (R-TN), quoted IDSA in his statement
at the hearing.
IDSA, the American College of Medical Genetics and Genomics, and the Association for Molecular Pathology hosted a congressional briefing the same day as the Senate hearing, featuring Dr. Caliendo and IDSA staff, to educate all congressional staff about LDTs and how they are used to guide effective patient care for a variety of diseases and conditions. IDSA and its partners also explained the consequences of proposed regulations that would limit the availability of some of these lifesaving tests.
The Food and Drug Administration (FDA) will hold a meeting in early November of the Microbiology Devices Panel of the Medical Devices Advisory Committee, to discuss and make recommendations regarding risk classification of tests for transplant-associated opportunistic viral infections. Highest risk tests will likely be the first to undergo any new regulations, and IDSA is advocating that tests for transplant viruses be classified as moderate- as opposed to high-risk. IDSA has asserted that these tests have been in use for many years by clinical laboratories, with well-documented data demonstrating clinical validity and peer reviewed literature supporting their use. In many instances, these LDTs have become the standard of care.
Congress and FDA continue to consider next steps on LDTs, such as revising and finalizing the draft FDA proposal, or crafting legislation to advance a different approach to LDT regulation, and IDSA will continue to be engaged.
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