October 25-28, 2026
Ernest N. Morial Convention Center | New Orleans, LA
Dual Purpose Analytes: CLIA Results in Biomarker Contexts of Use?
Joleen T. White, PhD
October 28 | 9:00 AM – 9:30 AM CT
Room 203–205
As clinical development becomes increasingly patient-centric, maximizing the scientific value of every sample is more important than ever. But can a clinical diagnostic result also serve as a biomarker for a different context of use?
In her presentation, Joleen will explore the scientific and regulatory considerations involved in using clinical laboratory data for biomarker purposes.
Using thyroid-related case studies, the presentation will examine:
- How clinical laboratory acceptance criteria compare with bioanalytical expectations
- How context of use influences the scientific risk of using diagnostic data as a biomarker
- Potential gaps between IVD/clinical laboratory methods and biomarker requirements
- When assay modifications, an LDT, or a dedicated biomarker assay may be appropriate
The discussion will provide a practical framework for evaluating these considerations before clinical studies begin to help teams make informed decisions about assay strategy, data utility, and regulatory expectations.
Connect with Joleen
Interested in discussing biomarker strategy, clinical laboratory data, context of use, or fit-for-purpose approaches?
Connect with Joleen T. White, PhD, at AAPS PharmSci 360 to continue the conversation or schedule a meeting.