269 - Lab-Developed Tests: Critical, But Are They “VALID”?

Saturday, October 14, 2023

3:15 PM – 4:30 PM US ET

Location: 210 ABC

All relevant financial disclosures have been mitigated.

Moderator(s)

Patricia (Trish) Simner, PhD, D(ABMM)

Clinical Microbiologist/Associate Professor
The Johns Hopkins University School of Medicine
Baltimore, MA, United States
Daniel Rhoads, MD

Section Head of Microbiology
Pathology and Laboratory Medicine Institute
Cleveland Clinic Foundation
Cleveland, OH, United States

Slides

Faculty(s)

Alex Greninger, MD, PhD, MS, MPhil

Larry Corey Endowed Associate Professor
University of Washington Medicine
Seattle, WA, United States

Slides
Melissa Miller, PhD (she/her/hers)

Professor
Pathology and Laboratory Medicine
University of North Carolina School of Medicine
Chapel Hill, NC, United States

Slides

Disclosure(s):

Patricia (Trish) Simner, PhD, D(ABMM): Affinity Biosensors: Grant/Research Support (Ongoing); BD Diagnostics: Advisor/Consultant (Ongoing), Grant/Research Support (Ongoing); Biomerieux: Advisor/Consultant (Ongoing); Entasis: Advisor/Consultant (Ongoing); GeneCapture: Advisor/Consultant (Ongoing); Merck: Advisor/Consultant (Ongoing); OpGen Diagnostics Inc: Advisor/Consultant (Ongoing), Grant/Research Support (Ongoing); Qiagen Sciences Inc: Advisor/Consultant (Ongoing), Grant/Research Support (Ongoing); Shionogi Inc: Advisor/Consultant (Ongoing)

Daniel D. Rhoads, MD: Abbott Diagnostics: Grant/Research Support (Ongoing); Altona Diagnostics: Grant/Research Support (Ongoing); bioMerieux Inc.: Grant/Research Support (Ongoing); Cepheid: Grant/Research Support (Ongoing), Honoraria (Ongoing); Cleveland Diagnostics: Grant/Research Support (Ongoing); DiaSorin: Advisor/Consultant (Ongoing); Hardy Diagnostics: Grant/Research Support (Ongoing); Helixbind: Grant/Research Support (Ongoing); Hologic: Grant/Research Support (Ongoing); Luminex: Grant/Research Support (Ongoing); Qiagen: Grant/Research Support (Ongoing); Q-Linea: Grant/Research Support (Ongoing); Roche Diagnostics: Advisor/Consultant (Ongoing), Grant/Research Support (Ongoing); Seegene: Advisor/Consultant (Ongoing); Specific Diagnostics: Grant/Research Support (Ongoing); Thermo Fisher: Advisor/Consultant (Ongoing), Grant/Research Support (Ongoing); Vela diagnostics: Grant/Research Support (Ongoing)

CME Credits: Maximum of 1.25 hours of AMA PRA Category 1 Credit™
MOC Credits: Maximum of 1.25 hours of MOC Credit
CNE Credits: Maximum of 1.25 hours of ANCC Credit
ACPE Credits: ACPE 1.25 knowledge-based contact hours of pharmacy CE
ACPE Number: JA0007082-0000-23-002-L01-P

Learning Objectives:

At the conclusion of this session, participants will be able to:

describe what is a laboratory-developed test and how they are validated for clinical care;
explain the current and emerging landscape of laboratory-developed tests for infectious disease diagnostics;
recognize the advantages and disadvantages of further regulation and oversight of laboratory-developed tests

Presentations:

3:15 PM – 3:40 PM US ET

What Is a LDT: Who Can Do Them, How Are They Validated, and Who Does the Oversight?
Speaker: Alex L. Greninger, MD, PhD, MS, MPhil – University of Washington Medicine
3:40 PM – 4:05 PM US ET

From AI to PCR & NGS: Examples of Laboratory-Developed Tests Used in Contemporary Clinical Practice
Speaker: Daniel D. Rhoads, MD – Cleveland Clinic Foundation
4:05 PM – 4:30 PM US ET

Debates About Regulation of LDTs: Are our concerns VALID?
Speaker: Melissa B. Miller, PhD (she/her/hers) – University of North Carolina School of Medicine