What: Live from the annual conference of the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), experts will discuss how FDA oversight of laboratory developed tests will hinder patient care.
Who:
Geoff Hollett, PhD, American Medical Association
Meghan Delaney, DO, MPH, Children's National Hospital
Sarah Braswell, Caregiver and Patient Advocate
Dennis Dietzen, PhD, DABCC, FADLM, Washington University School of Medicine
Olivia Braswell, Patient
When: July 30, 2024 at 5:30 PM ET
Where: Newswise Live Zoom Room (address will be included in follow-up email)
A laboratory developed test is a new or significantly modified test that is developed, validated, and used by highly trained laboratory medicine professionals within a single clinical laboratory in response to a specific patient care need. Most laboratory developed tests are created because no Food and Drug Administration (FDA)-approved test is available, and they are often used to diagnose rare conditions, such as inherited genetic disorders in newborns.
Laboratory developed tests are already subject to rigorous oversight by the Centers for Medicare & Medicaid Services. However, the FDA has now released a final rule bringing laboratory developed tests under FDA oversight as well. This duplicative regulation will force many labs to stop performing these essential tests, which could harm patients by significantly delaying diagnoses and care.
In this special session, experts from ADLM, the American Medical Association, and the Children’s Hospital Association will discuss how the FDA’s new rule will impede healthcare professionals’ ability to provide quality patient care. Attendees of this session will also hear from a caregiver and patient advocate on the importance of laboratory developed tests in diagnosing medical conditions. The session will close with the speakers taking questions directly from the audience.
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