Published in JCO Precision Oncology, the new analytical validation standards offer an industry-wide protocol for test developers
CHICAGO, Jan. 15, 2026 /PRNewswire/ -- A new consensus document developed by The Blood Profiling Atlas in Cancer (BLOODPAC) Consortium was published in JCO Precision Oncology. The publication provides generic protocols for the analytical validation of tumor-informed ctDNA assays for Molecular Residual Disease (MRD) liquid biopsy tests. MRD tests are designed to identify the molecular "fingerprints" of cancer associated with a remnant or recurrence of residual disease following treatment and can be used to help monitor patient response to treatments in real time and inform treatment decisions.
The manuscript "Generic Protocols for Analytical Validation of Tumor-Informed Circulating Tumor DNA Assays for Molecular Residual Disease: The Blood Profiling Atlas in Cancer's Molecular Residual Disease Analytical Validation Working Group Consensus Recommendation" was developed by BLOODPAC's MRD Analytical Validation Working Group and establishes a core set of generic protocols to support companies as they design and conduct analytical validation studies for MRD assays. The protocols can be adapted and applied to any tumor-informed MRD assay, irrespective of technology-next-generation sequencing (NGS) or digital PCR (dPCR), panel design algorithm, or workflow component.
"These protocols reflect a deep collaborative effort and a shared commitment to advancing high-quality, reproducible MRD testing," said Lauren Leiman, Executive Director of BLOODPAC. "By providing a unified framework for analytical validation, BLOODPAC is helping to accelerate the development of trustworthy ctDNA MRD assays that will benefit patients."
Advances in the development of tumor-informed MRD assays are poised to transform how clinicians monitor for recurrence and inform decisions during treatment. However, variability in how analytical validation studies are designed and conducted creates challenges for both developers and regulators. The BLOODPAC protocols address these challenges head-on by:
- Providing guidance for determining key analytical performance characteristics, including limit of blank (LoB), limit of detection (LoD), accuracy, and precision.
- Addressing additional factors that influence assay performance, such as guard banding, to establish assay robustness, specimen stability during preparation and shipping, and assessment of interfering substances that may impact accuracy.
- Recommending methods for evaluating contrived and clinical sample comparability, ensuring that reference materials used in assay validation perform the same as patient-derived cfDNA samples.
"MRD is being established as a relevant biomarker across multiple solid tumor malignancies. Developing a unified framework of analytical standards is essential to ensure these assays are validated quickly, deliver robust and reproducible results, and can be confidently adopted in clinical practice. Driving this new framework forward will advance patient access to personalized treatments," said Jonathan Baden, Executive Director & Head of Precision Medicine of Bristol Myers Squibb.
"BLOODPAC's goal is to give developers a clear foundation for demonstrating the analytical performance of ctDNA MRD assays-no matter the technology-so that the focus can shift more quickly to what matters most: delivering reliable tests that inform patient care," said Leiman.
The BLOODPAC MRD Analytical Validation Working Group represents a cross-section of experts across biotech and pharma industries, academia, and regulatory sectors. Contributors to the protocols include leading experts in molecular diagnostics, bioinformatics, oncology, and regulatory science.
These new protocols build on BLOODPAC's ongoing work to establish industry-wide standards for test validation. Most recently, BLOODPAC published recommendations in the Journal of Molecular Diagnostics outlining key technical and biological considerations for the analytical validation of blood-based tumor mutational burden (bTMB) assays, which hold promise for predicting response to immunotherapy in patients with advanced and metastatic solid tumors. BLOODPAC's earlier publication of generic analytical protocols in Clinical Chemistry helped define industry standards for the development of Next-Generation Sequencing-Based ctDNA liquid biopsy tests.
About BLOODPAC
BLOODPAC is a consortium managed by the Center for Computational Science Research, Inc. (CCSR), which is an Illinois based 501 (c)(3) not-for-profit corporation. Our mission is to accelerate the development, validation, and accessibility of liquid biopsy assays to improve outcomes for patients with cancer. To do so, we lead a pre-competitive international collaborative infrastructure that enables the sharing of information and building of consensus among stakeholders in industry, academia, regulatory bodies, payers, and government agencies.
Contact: Berna Diehl, berna@bloodpac.org
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