The effects of the U.S. Food and Drug Administration's (FDA) final rule on laboratory-developed tests (LDTs) on patient care were the topic of a special session held on the evening of June 30 at the Association for Diagnostics & Laboratory Medicine (ADLM) annual meeting in Chicago.
ADLM President Octavia Peck Palmer, PhD, moderated the session that was entitled "How FDA Oversight of LDTs Will Affect Patient Care: A Conversation With ADLM, the American Medical Association, the Children's Hospital Association, and a Patient Advocate."
The ADLM has previously expressed concerns about the FDA's final rule, which was announced on May 6. The organization surveyed its members and sent the results from the 128 responses it received to the U.S. Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce along with a letter summarizing the concerns. The organization also signed a letter in November 2023 requesting that Congress update CLIA as an alternative to the then-proposed LDT rule.
Featured speakers of the session included Geoff Hollett, PhD, a senior policy analyst representing the American Medical Association; Meghan Delaney, DO, MPH, representing the Children's Hospital Association; Sarah Braswell, a caregiver and patient advocate, offering a patient's perspective; and Dennis Dietzen, PhD, representing the ADLM's Policy and External Affairs Core Committee. The session concluded with panel discussion questions submitted by audience members.
The focus of the presentations included an emphasis on the power of effective LDTs in treatment plans and patient care, especially in newborn screening and pediatric care, and concerns that the restrictions imposed by the FDA's final rule could undermine the ability of healthcare providers to develop treatment plans and provide care promptly.
"Undeniably, LDTs play a vital role in fulfilling specific and unmet medical needs. However, the FDA's final rule and the prospect of heightened regulatory oversight may jeopardize the ability of laboratory professionals to utilize their expertise to meet patient care needs. Moreover, it will negatively affect our patients," the ADLM said in a summary of the session that was published on its meeting site.
