Why Minimal Residual Disease (MRD) Testing Is Gaining Ground And How Labs Can Get In Now
Minimal Residual Disease (MRD) refers to the small number of cancer cells that remain in a patient’s body during or after treatment; cells that standard lab tests and imaging often miss (National Cancer Institute, n.d.). MRD monitoring is rapidly becoming one of the most sought-after genomics applications in oncology, especially for managing chronic myelogenous leukemia (CML), where detection of BCR-ABL fusion transcripts plays a central role in treatment guidance (Short et al., 2021).
MRD assays like Bio-Rad’s FDA-cleared QXDx BCR-ABL %IS test are uniquely suited for repeated use across the patient’s treatment journey (Centers for Medicare & Medicaid Services [CMS], 2023). These aren’t one-time genomic snapshots, they are serial measurements that track a patient’s response to therapy over time. FDA documentation and clinical usage guidelines support ongoing use throughout the duration of tyrosine kinase inhibitor (TKI) therapy (FDA, 2019). In some clinical settings, this can lead to patients receiving 20 or more MRD tests over the course of their treatment plans, though formal public documentation of that exact frequency is limited and often derived from internal or unpublished experience.
One of the key benefits for labs is that this assay is an FDA-cleared in vitro diagnostic (IVD), which means it can be adopted without the lengthy validation processes typically required for laboratory-developed tests (Blue Cross Blue Shield of Rhode Island, 2025). With a Bio-Rad QXDx AutoDG digital droplet PCR (ddPCR) system and the QXDx kit, labs can stand up a highly precise MRD workflow using infrastructure that’s both straightforward and scalable (Bio-Rad Laboratories, n.d.).
Where Bitscopic Fits In
While the molecular testing is handled by the Bio-Rad kit, Bitscopic’s PraediGene platform supports clinical labs with a simplified downstream data and reporting experience. Labs use PraediGene to:
- View and organize sequential BCR-ABL reports per patient
- Track MRD trends and treatment response over time
- Deliver clear, longitudinal reports that clinicians can act onspan>
- Integrate seamlessly with existing LIMS for streamlined workflows
It’s a clean handoff from test to insight, no custom bioinformatics needed. This model is already in use within VA laboratories and is helping shape future MRD adoption pathways.
Why MRD is Increasing in Importance
In genomics circles, the value of MRD is multiplying. Researchers and bioinformatics teams increasingly view it as a highly relevant and high-profile area to be involved in. It’s not just the clinical utility; working on MRD has become a marker of innovation, drawing attention from labs, research programs, and commercial testing platforms (Krivoy & Masarwa, 2023; Loria, 2023). As MRD continues to shift from “cutting edge” to “clinical standard,” institutions not yet performing these tests may feel pressure to catch up.
READY TO BRING MRD MONITORING IN-HOUSE?
PraediGene can help you operationalize a high-demand assay, streamline reporting, and elevate your institution’s precision medicine footprint – all without building new infrastructure from scratch.