Achyut Saroj, Founder, Consultant, and Author at AwareOnc, KOL Engagement and Medical Affairs Liaison at Tatva Health, shared a post on LinkedIn:
“Exciting news for the liquid biopsy and oncology communities!
A new study from the BLOODPAC Consortium introduces a consensus recommendation for standardized analytical validation (AV) protocols specifically for tumor-informed ctDNA assays used to detect Molecular Residual Disease (MRD).
The Challenge: Precision at the Extreme
Detecting MRD after curative-intent therapy is like finding a needle in a haystack because ctDNA concentrations can be extremely low, often just a few molecules per milliliter of plasma.
While tumor-informed assays, which track a patient’s unique mutations, offer ultra-high sensitivity, their personalized nature makes traditional validation complex.
The Solution: A Regulatory Roadmap
To streamline the path to clinical use, the BLOODPAC MRD AV Working Group collaborated with industry leaders, academia, and the FDA to develop a set of generic protocols.
These provide a foundational framework for essential performance metrics, including:
- Limit of Blank (LoB) and Limit of Detection (LoD) to ensure high-sensitivity reliability.
- Analytical Accuracy and Precision across different operators and instruments.
- Robustness and Stability testing to ensure assays perform under real-world conditions.
Why This Matters?
These protocols are technology-agnostic, meaning they can be adapted for any tumor-informed MRD assay regardless of whether it uses NGS, digital PCR, or a specific panel design.
By providing a standardized baseline, these guidelines aim to accelerate regulatory reviews and help developers bring highly sensitive, reliable diagnostic tools to patients faster.
Standardizing how we measure success in liquid biopsy is a critical step toward making personalized cancer monitoring a routine part of patient care.”
Title: 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
Authors: Jonathan Baden, Cheng-Ho Jimmy Lin, Andrew T. Anfora, Jonathan Beer, Karl Bisselou, Jennifer Bungo, Adam S. Corner, Tyler Danek, Jennifer Dickey, James H. Godsey, Donald J. Johann, Gregory Jones, George Karlin-Neumann, Jessica L. Larson, Jerry S.H. Lee, Li Liu, Dorys Lopez Ramos, David Merriam, Melanie Palomares, Carol E. Pena, Jessica Rathbun, Kate Rhodes, Jaime E. Connolly Rohrbach, Banu Saritas-Yildirim, Mark Sausen, Shile Zhang, Lauren C. Leiman
Read the Full Article on JCO Precision Oncology
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