Improving Patient Access to Liquid Biopsy Collection: Regulatory Strategies & Efficiencies

BLOODPAC’s Blood Collection and Distribution Working Group hosted a virtual workshop focused on advancing best practices in liquid biopsy specimen collection. This session built upon BLOODPAC’s recent pre-submission to the U.S. Food and Drug Administration (FDA), Increasing Patient Access and Standardizing Patient Blood Collection.

During the workshop, BLOODPAC presented proposed regulatory pathways for liquid biopsy specimen collection and invited stakeholder feedback to help refine key recommendations. Input gathered during the discussion will directly inform a forthcoming BLOODPAC publication aimed at guiding future efforts across the field.

The program included a 60-minute panel discussion moderated by Jennifer Dickey (PGDx/Labcorp) and featuring two speakers from the FDA. Panelists explored three potential regulatory approaches:

• Regulatory Pathway 1: Materials Required but Not Supplied

• Regulatory Pathway 2: Assay-Specific Specimen Collection Kits

• Regulatory Pathway 3: Universal Collection Kits

This workshop was open exclusively to BLOODPAC members and was not recorded. Insights from the discussion will contribute to an upcoming BLOODPAC publication.