January 30, 2025
11 a.m. EST
In oncology, companion diagnostics (CDx) are crucial for identifying patients who are most likely to benefit from a particular cancer therapy based on their biomarker status. This personalized approach enhances treatment efficacy, minimizes adverse effects, and contributes to more efficient clinical trials by focusing on defined patient populations.
As the application of CDx in oncology therapeutic development has increased, so has regulatory scrutiny. Beginning May of 2025, manufacturers will face more stringent requirements for analytical and clinical validation of laboratory-developed tests (LDTs), including CDx. This shift in regulatory requirements may demand additional resources, lengthen development timelines, and increase operational complexity.
In this webinar, we will explore the shifting landscape of CDx in oncology, highlighting key regulatory, assay development, and study design considerations for biomarker-guided clinical trials.
Topics will include:
- The regulatory landscape for CDx, including recent changes to the regulation of LDTs
- Impact of the changing regulations in current applications of CDx in oncology trials
- Considerations for assay development
- Strategies for designing clinical trials with CDx in mind
Speakers:
Meera Belur, Executive Director, Program Strategy, Oncology
Charlie Chrisawn, Executive Director, Program Strategy, Diagnostics
Perspectives Blog 