LDT special session

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

Tuesday, July 30
4:30 p.m. – 6 p.m.
McCormick Place Convention Center
Grand Ballroom (S100)

The US Food and Drug Administration released a final rule expanding agency oversight of laboratory developed tests (LDTs). This regulatory action will significantly impact patient care, limiting the ability of physicians to order rare and modified diagnostic tests. In addition, the new rule will result in many laboratories discontinuing LDTs, forcing them to send their critical tests offsite and thereby further delaying diagnosis and treatment. Representatives from ADLM, the American Medical Association, and the Children’s Hospital Association will discuss how these challenges will affect their members' ability to provide quality patient care. Attendees of this special session will also hear from a caregiver and patient advocate on the importance of LDTs in diagnosing medical conditions. The session will close with a panel of our experts taking questions directly from the audience.

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Moderator

Octavia Peck Palmer, PhD, FADLM
University of Pittsburgh Medical Center, Pittsburgh, PA

Speakers

• The New FDA Rule on LDTs: A Physician Perspective
  Geoff Hollett, PhD, American Medical Association Representative, Chicago, IL
• What the New FDA Rule Means for Pediatric Care
  Meghan Delaney, DO, MPH, Children’s Hospital Association Representative, Washington, DC
• The Value of LDTs: A Parent’s Perspective
  Sarah Braswell, Caregiver and Patient Advocate, Sterling, VA

Additional panelists

• Olivia Braswell, Patient Representative, Sterling, VA
• Dennis Dietzen, PhD, DABCC, FADLM, Washington University School of Medicine/St. Louis Children’s Hospital, St. Louis, MO