Back in November 2024, The Pathologist attended the Association for Molecular Pathology (AMP) annual meeting and expo. It was a valuable community event and provided many opportunities to connect with leaders across the field. One of our highlights was a Fireside Chat (which you can read more about here) focused on bridging the gaps in implementing minimal residual disease (MRD) testing in clinical practice for oncology.
We caught up with panelist Ramin Dowlati, director of precision medicine at Johnson&Johnson, to further this conversation.
How do you view the role of MRD testing in the current diagnostic landscape?
It’s an interesting question. For several years now, in many countries, there has been routine testing for BCR-ABL in patients with chronic myeloid leukemia to establish the level of molecular response and to monitor changes over time. While we may not refer to it as MRD, this test has been used in routine patient care and is generally reimbursed. In this setting, MRD testing has played a critical role in assessing disease burden and is widely available through diagnostic laboratories.
To advance the use of MRD as a diagnostic tool, collaboration across multiple stakeholders – including diagnostic companies, academia, and research cooperative groups – is essential. With the FDA’s Oncologic Drugs Advisory Committee vote in favor of MRD testing in multiple myeloma trials earlier this year, we can expect its role to expand as a key biomarker in both hematologic malignancies and solid tumors. More broadly, widespread adoption in clinical practice will depend on demonstrating clinical utility and ensuring reimbursement.
In solid tumors, MRD testing is still in the early stages of integration for colorectal cancer (CRC), where it is being used for risk stratification and disease monitoring. Fortunately, there is a growing number of high-quality send-out tests, with increasing reimbursement from payors. In the near future, we may see commercially available MRD test kits entering the market. Leveraging insights from hematologic malignancies and CRC could help accelerate the adoption of MRD diagnostics in other solid tumors, ultimately improving disease monitoring and patient outcomes.
With the rise of personalized medicine, how has MRD testing adapted to become more patient-specific, and what challenges does this present in the laboratory setting?
One of the main applications of MRD, which is to detect relapse before it becomes clinically symptomatic, is very much in the spirit of personalized medicine. Current MRD testing, whether tumor-informed or tumor-agnostic, uses liquid biopsy (ctDNA) for detecting MRD. I think there are valuable lessons to be learned from the challenges and opportunities in access and adoption of liquid biopsy in a prognostic setting – there is still great potential of liquid biopsy in personalized medicine to guide targeted treatment decisions.
Of course, there are a number of variables through clinician adoption and order of tests. From a lab perspective, the challenges include harmonization of pre-analytics, standardization of testing protocols, the need for robust reference standards (globally), time points for testing, clear interpretation of results, and so forth. Again, I think there are some common challenges with existing use of liquid biopsy that we could learn from to help access and adoption of MRD in routine clinical care.
What developments do you anticipate in MRD testing over the next five to ten years, and how should laboratories prepare for them?
While MRD has a stronger base of clinical utility in hemato-oncology, I believe we will see an accelerated pace and expansion of development of MRD testing in select solid tumor applications given the pace of development in CRC. In terms of technology, we can expect advancements in platforms such as NGS and digital PCR to improve sensitivity and bioinformatics, which may play an important role.
Of course, improvement in sensitivity should not come at the cost of specificity, and demonstrating clinical relevance at lower and lower sensitivity will continue to be a challenge. In the same context, improvements in technology creates challenges in standardization and I think that’s one of the challenges labs will face. Which technology do they invest in? When do they invest? What impact will this have on current operations, workflow, personnel? Will the new technologies be complimented with the required quality assurance programs? There are many variables for labs to consider in preparing for future developments in MRD.
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