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.
, /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.
Beginning May of 2025, manufacturers will face more stringent requirements for analytical and clinical validation of laboratory-developed tests (LDTs), including CDx.
With the increase in the application of CDx in oncology therapeutic development, regulatory scrutiny …