How We Work

The Data Science Working Group is focused on advancing the BLOODPAC Portal as a trusted, collaborative platform for storing, sharing, and analyzing liquid biopsy datasets and related publications. Through cross-disciplinary collaboration, the group drives data-driven insights to accelerate research and improve patient outcomes. Learn more.

The bTMB Analytical Validation Working Group was established by BLOODPAC, in collaboration with Friends of Cancer Research, to support the development of best practices for analytically validating blood-based tumor mutational burden (bTMB) tests. With a range of assay designs in development, the group’s publication aims to increase standardization while recognizing the need for flexible, test-specific approaches. Its goal is to provide a foundational framework to guide developers as they design and validate bTMB assays for solid tumors. Learn more.

• This group is paused and will be returning Summer 2027.

The Brain Tumor Working Group is focused on advancing liquid biopsy for primary brain tumors, with an initial emphasis on cerebrospinal fluid (CSF) ctDNA genomic profiling. The group’s initial project brought together experts from clinical neuro-oncology, academia, and industry to identify key preanalytical variables and support the development of a CSF dataset within the BLOODPAC Data Commons. Its long-term goal is to enable routine clinical use of liquid biopsy for brain tumors.

• This working group has been put on hold and is not currently accepting new members.

The Clonal Hematopoiesis of Indeterminate Potential (CHIP) Working Group focuses on standardizing CHIP-related terminology, detection methods, and biomarker classification criteria. Bringing together stakeholders from across research and clinical domains, the group aims to align the field around a common lexicon, clarify the clinical and translational relevance of CHIP, and promote consistent approaches to detection—including matched buffy coat analysis, algorithmic methods, and gene frequency evaluation. Learn more.

The Early Cancer Detection and Screening (ED&S) Working Group brings together leaders from industry, academia, non-profits, policy, regulatory, and reimbursement communities to advance blood-based technologies for early cancer detection. The group aims to build consensus around common definitions and standardized frameworks for evidence development, addressing key gaps in clinical validation, clinical utility, and overall lexicon. Through collaboration and publication, the group works to align stakeholders and support progress in this rapidly evolving field. Learn more.

The Generic Protocols for the Analytical Validation of cfDNA Assays Working Group brings together stakeholders across the liquid biopsy field to support the development and standardization of analytical validation practices for cell-free DNA assays. By fostering collaboration among test developers, regulators, and clinical laboratories, the group aims to align industry efforts and promote regulatory clarity. A dedicated subgroup, the bTMB Analytical Validation Working Group, focuses specifically on blood-based tumor mutational burden assays. Learn more.

• This group is currently paused and is not accepting new members.

The JUST FREAKING DO IT! (JFDI) Working Group is focused on improving the quality and consistency of ctDNA analysis through inter-laboratory testing of established analytical tools and reference materials. By measuring accuracy, precision, and other key performance metrics, the group aims to advance standardization and reliability in ctDNA testing—an essential step as liquid biopsy increasingly informs clinical decision-making. The JFDI team includes ten independent BLOODPAC member laboratories committed to this effort. Learn more.

• This group is not currently accepting new members.

The Molecular Residual Disease (MRD) Strategic Steering Group aims to identify and overcome barriers to implementing MRD in non-metastatic solid tumors. Its long-term objective is to support the validation of MRD as an early endpoint in clinical trials. The group guides three subgroups—MRD Analytical Validation, MRD Clinical Utility, MRD Clinical Validation, and MRD DLBCL—each focused on specific challenges to MRD adoption. Learn more.

The MRD Analytical Validation Working Group focuses on developing generic analytical validation protocols for blood-based molecular residual disease (MRD) testing in solid tumors. The group aims to support the use of MRD as a diagnostic tool to detect residual or recurrent disease following clinical intervention and to inform treatment decisions throughout the patient journey, ultimately improving outcomes and reducing costs. Learn more.

The MRD Clinical Validation Working Group is focused on advancing the clinical validation and utility of ctDNA-based MRD testing. The group is defining key clinical applications across the patient journey and identifying the study design elements needed to support those use cases. After a review of the current landscape, the group will prioritize one application for initial focus, with others to follow. Insights from this process will be captured in a white paper to help guide future efforts and support broader adoption of MRD testing in patient care. Learn more.

The group is focusing on addressing two critical gaps preventing the widespread adoption of liquid biopsy in Diffuse Large B-Cell Lymphoma (DLBCL): the lack of technical standardization and the lack of a validated surrogate endpoint. Initial efforts of the working group are centered on two key areas. First, the group will review the existing MRD lexicon to identify overlaps and gaps specific to hematologic applications. Second, it will define technical and patient requirements, including Target Product Profiles and minimum effective parameters, while evaluating the balance between assay sensitivity and patient burden. Learn more.

This group will focus on developing best practices and standards for multi-omics analytics and AI, with the goal of supporting a future publication and potential pre-submission activities. Initially, efforts will center on assay discovery, including defining use cases, platforms, data types, performance metrics, and establishing a common lexicon and guidelines. Subsequently, the group will shift to assay validation, addressing validation design, analytical and clinical considerations, and potential regulatory pathways. Learn more.

This group will oversee the development of a pre-analytical lexicon publication and create guidance on design considerations for multi-omic tests, spanning both pre-analytical and analytical aspects. First, the focus will be on advancing the lexicon publication and selecting a representative multi-omic test to map step-by-step study design, including key pre-analytical and analytical considerations. Next, the group will develop a universal pre-study checklist to guide sample collection, handling, extraction, and data generation, with plans for pre-submission and publication. During this phase, the group will also begin drafting an analytic validation guidance document for the selected example test. Learn more.

The Recommended Data Element (RDE) Working Groups focus on defining and validating minimal technical data elements (MTDEs) for consistent data submission to public databases and repositories. Learn more.

The Accessibility Working Group aims to identify and address barriers to equitable clinical use of liquid biopsy tests, focusing on reducing disparities and expanding access. Its goal is to ensure that precision medicine technologies improve outcomes across all communities. The group includes two subgroups: Blood Collection and Clinician Education & Access. Learn more.

The Blood Collection Working Group, a subgroup of the Accessibility Working Group, is dedicated to simplifying and standardizing blood collection for liquid biopsy diagnostics. By advancing an assay-agnostic approach, the group works to improve equitable access and minimize dependence on proprietary collection kits. Learn more.

The Clinician Education and Access Working Group, a subgroup of the Accessibility Working Group, focuses on understanding clinician perceptions and use of liquid biopsies, with the goal of promoting their broader adoption in clinical practice. Learn more.

The Global Regulatory Working Group focuses on harmonizing international regulatory standards for liquid biopsy diagnostics. Its goal is to streamline regulatory review and accelerate approval to benefit patients worldwide. In the near term, the group is building global partnerships and gathering feedback on BLOODPAC deliverables, with plans to develop further resources in collaboration with regulatory agencies. Learn more.

The Reimbursement & Policy Working Group brings together experts in market access, health economics, and regulation to address payer coverage gaps for liquid biopsy. By building a unified payer education framework and engaging policymakers, the group aims to improve patient access and outcomes through expanded coverage, coding, and payment for these essential tests. Learn more.