In this free webinar, learn about the regulatory landscape for companion diagnostics (CDx), including recent changes to the regulation of laboratory-developed tests (LDTs). The featured speakers will discuss the impact of the changing regulations in current applications of CDx in oncology trials. Attendees will gain insights into considerations for assay development and strategies for designing clinical trials with CDx in mind.
TORONTO, Jan. 10, 2025 /PRNewswire-PRWeb/ -- 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 targeted patient selection, treatment efficacy, minimizes adverse effects and contributes to more efficient clinical trials by focusing on defined patient populations.
With the increase in the application of CDx in oncology therapeutic development, regulatory scrutiny has intensified. 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, the expert speakers will explore the shifting landscape of CDx in oncology, highlighting key regulatory, assay development and study design considerations for biomarker-guided clinical trials.
Join experts from , Meera Belur, Executive Director, Program Strategy, Oncology; and Charlie Chrisawn, Executive Director, Program Strategy, Diagnostics, for the on Thursday, January 30, 2025, at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit .
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