CLN Daily 2024
Laboratory developed tests (LDTs) are indispensable and often hold the key to identifying rare medical conditions. They also provide critical data to clinicians when existing FDA cleared tests fall short. However, on May 6, 2024, the FDA announced a final rule extending its oversight to LDTs, sending shockwaves throughout the healthcare community. This regulatory action is poised to have a significant impact on patient care, as it may limit the ability of physicians to order specialized diagnostic tests. On Tuesday evening, ADLM President Octavia Peck Palmer, PhD, DABCC, moderated a special session on LDTs, “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 session began with a video highlighting the power of LDTs, with an emphasis on newborn screening. The immediacy of newborn screening results provided life-altering information that greatly impacted children’s lives at the time of testing, but also their care for years to come. The film set the focus for the session on the most vulnerable of patients: children.
Geoff Hollett, PhD, a senior policy analyst representing the American Medical Association, emphasized the way the rule will undermine clinician’s ability to provide care. “FDA’s rule was developed at lightning speed with minimal input from the public,” Hollet added.
Another key point Hollett made was the uncertainty that shrouds the final rule. With uncertainty comes abstention, Hollet posited: “Practices will close, effective tests will not be offered, and patient care will get worse because of fear of noncompliance.”
Representing the Children’s Hospital Association, Meghan Delaney, DO, MPH, next commented on the vital role of LDTs in pediatric care, emphasizing the devastating impact of the new FDA rule in this patient population. “There is no difference in how [FDA approved and laboratory developed] tests perform,” Delaney said. “They are accurate and provide clinical information for patients and physicians.” Delaney also noted that the “additional administrative burden and associated costs have serious implications for our ability to provide timely diagnostics for the nation’s children.”
Sarah Braswell, a caregiver and patient advocate, rounded out the presentations by illustrating the value of LDTs from a parent’s perspective. Sharing the story of her daughter, Olivia, Braswell detailed the critical role LDTs have played in ensuring the highest quality of care in diagnosing and managing Olivia’s Down Syndrome. Since individuals with Down Syndrome are at increased risk of developing health conditions such as cancer, Braswell regularly advocates for timely testing for Olivia. Many of those tests are LDTs.
The session concluded with panel discussion questions submitted by the audience. Joined by Dennis Dietzen, PhD, DABCC, representing ADLM’s Policy and External Affairs Core Committee, the speakers agreed that if the ruling remains unchanged, it will severely reduce patient access to quality healthcare. Dietzen implored us all to amplify this message. The highlight of the session was when participants were joined by Olivia on stage, smiling and waving at the audience.
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.