99 - Diagnostic Trials: Past and Future

Tuesday, October 21, 2025

8:00 AM - 9:00 AM US ET

Location: B211-B212

CME Credits: Maximum of 1 hours of AMA PRA Category 1 Credit™
MOC Credits: Maximum of 1 hours of MOC Credit
CNE Credits: Maximum of 1 hours of ANCC Credit
ACPE Credits: ACPE 1 knowledge-based contact hours of pharmacy CE
ACPE Number: JA0007082-9999-24-002-L01-P
PACE Credits: Maximum of 1 of PACE contact hours
CE Broker: Maximum of 1 CE broker credit hours

Moderator(s)

RB

Ritu Banerjee, MD, Ph.D (she/her/hers)

Professor
Pediatric Infectious Diseases
Vanderbilt University Medical Center
Nashville, TN, United States
Robin Patel, MD (she/her/hers)

Professor
Mayo Clinic
Rochester, MN, United States

Faculty(s)

MS

Michael Satlin, MD, MS

Associate Professor
Medicine
Weill Cornell Medicine
New York, NY, United States
SD

Sarah Doernberg, MD, MAS (she/her/hers)

Professor of Medicine
Medicine, Infectious
University of California, San Francisco
San Francsisco, California, United States

Disclosure(s):

Ritu Banerjee, MD, Ph.D: Biomerieux/Biofire diagnositcs: Grant/Research Support

Robin Patel, MD: a patent on Bordetella pertussis/parapertussis PCR issued, a patent on a device/method for sonication, a patent on PET imaging of bacterial infection with a PET probe filed, and a patent on an anti-biofilm substance issued: a patent on Bordetella pertussis/parapertussis PCR issued, a patent on a device/method for sonication, a patent on PET imaging of bacterial infection; MicuRx Pharmaceuticals and bioMérieux: Grant/Research Support; PhAST, Day Zero Diagnostics, DEEPULL DIAGNOSTICS, S.L., Nostics, HealthTrackRx, bioMérieux and CARB-X: Advisor/Consultant; Up-to-Date and the Infectious Diseases Board Review Course: Honoraria

Michael J. Satlin, MD, MS: AbbVie: DSMB participant; bioMerieux: Grant/Research Support; Merck: Grant/Research Support; SNIPRBiome: Grant/Research Support

Sarah B. Doernberg, MD, MAS: AstraZeneca: Advisor/Consultant; Basilea Pharmaceutica: Grant/Research Support; F2G Ltd.: Grant/Research Support; Pfizer, Inc.: Grant/Research Support; Shinogi: Grant/Research Support

Learning Objectives:

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

describe study designs used to evaluate the impact of diagnostic tests on clinical outcomes;
describe study designs used to evaluate diagnostic test performance;
identify strengths and limitations of various trial designs for infectious disease diagnostics.

Presentations:

8:00 AM - 8:30 AM US ET

Evaluation of Infectious Disease Diagnostics: Innovative Study Designs to Assess Test Performance
Speaker: Michael J. Satlin, MD, MS – Weill Cornell Medicine
8:30 AM - 9:00 AM US ET

Evaluation of Infectious Disease Diagnostics: Study Designs to Assess Impact on Clinical Outcomes
Speaker: Sarah B. Doernberg, MD, MAS (she/her/hers) – University of California, San Francisco