BLOODPAC's collaborations with European Union liquid biopsy initiatives

The adoption of liquid biopsy into clinical practice has revolutionized the landscape of cancer diagnostics and treatment monitoring. In the U.S., the Blood Profiling Atlas in Cancer (BLOODPAC) has significantly supported the advancement of these technologies through consensus building [1]. In collaboration with the United States (US) Food and Drug Administration (FDA), BLOODPAC has developed minimum technical data elements (MTDEs) and analytical validation protocols to streamline the assay development and regulatory assessment of liquid biopsy-based technologies. Additionally, BLOODPAC has established a pre-competitive data sharing model to support clinical implementation.

The European Union faces regulatory and access challenges that hinder widespread adoption of liquid biopsy technologies. Complexities under the In Vitro Diagnostic Regulation (IVDR) and Clinical Trials Regulation (CTR) have introduced variability and delays across member states. While recognizing Europe's strengths in developing robust frameworks and high standards for advancing precision oncology, this paper explores how BLOODPAC's efforts—particularly in standardization, validation, and data sharing—could inform and complement EU initiatives. BLOODPAC's experience in developing fit-for-purpose validation frameworks and fostering regulatory-industry dialogue offers particularly relevant insights for addressing EU-specific challenges. This paper proposes opportunities for collaboration and guidance development that could enhance European access to liquid biopsy-based tests for precision medicine, ultimately improving patient access and outcomes for cancer care and management.