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Liquid biopsy regulatory considerations, current utility, and future directions

The future is plasma. There is a growing body of evidence that demonstrates how incorporating liquid biopsy-based testing into cancer clinical trials can augment traditional tissue-based testing workflows and findings. A paired tissue-plasma strategy can enhance testing access and flexibility, increase eligible patient populations, and uncover more therapeutically targetable mutations that tissue-only testing misses.1 There are several factors driving increased awareness and interest of liquid biopsy testing in the precision oncology space. Not only can plasma-based tests add new diagnostic options, they also yield actionable insights for a greater number of patients.1 In recent years, the number of approvals for tissue and plasma-based companion diagnostics has notably increased.2 Additionally, the FDA released a draft guidance in 2022 to inform sponsors on how to use cfDNA in clinical trials and to support marketing approvals.3 The movement to overcome the challenges of a tissue-only approach and set a new gold standard in precision oncology with liquid biopsy testing is gaining momentum. However, the introduction of liquid biopsy in clinical trials will impact trial strategy and design. It's imperative that researchers understand the regulatory considerations and how to overcome them for a seamless research experience.

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Regulatory Strategy