Generic Protocols for the Analytical Validation of Next-Generation Sequencing-Based ctDNA Assays Version 2.0

Written By Cheyenne Jankiewicz

BLOODPAC’s Analytical Validation Working Group published Generic Protocols for the Analytical Validation of Next-Generation Sequencing-Based ctDNA Assays Version 2.0 in JCO Precision Oncology. This updated publication builds on the original 2020 analytical validation protocols developed to support the validation of NGS-based circulating tumor DNA (ctDNA) assays. Version 2.0 incorporates feedback gathered through real-world use, including comments from nine institutions and regulatory input to ensure the protocols remain practical, scientifically rigorous, and relevant in a rapidly evolving field.

The updated protocols reflect BLOODPAC’s ongoing commitment to advancing high-quality liquid biopsy testing and maintaining community-driven resources that support assay developers, regulatory discussions, and broader clinical adoption.

Check out the full publication here: https://ascopubs.org/doi/10.1200/PO-25-01243

Cheyenne Jankiewicz
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