Generic Protocols for the Analytical Validation of Next-Generation Sequencing-Based ctDNA Assays: A Joint Consensus Recommendation of the BloodPAC's Analytical Variables Working Group

Analytical validation is essential to ensuring circulating tumor DNA (ctDNA)-based liquid biopsy tests are accurate, reliable, and ready for clinical use. In this publication, BLOODPAC's Analytical Variables Working Group outlines a set of consensus analytical validation protocols for ctDNA-based next-generation sequencing (NGS) assays. The guidance addresses the unique challenges of detecting rare tumor-derived DNA in blood and provides best practices to support assay developers, facilitate FDA presubmission discussions, and promote greater consistency and efficiency across the field. By establishing a common framework for analytical validation, this work helps accelerate the development and adoption of high-quality liquid biopsy tests for patients with cancer.

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