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What gets measured gets managed™

WHAT IS MRD?

Measurable Residual Disease

Measurable (or minimal) residual disease (MRD) refers to the small number of cancer cells that can remain in a patient’s body during and after treatment and may eventually cause recurrence of the disease. These residual cells typically cause no physical signs or symptoms and are present at such low levels that more refined and sensitive techniques are required to identify them.

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Diagnosis

Remission

Molecular
Relapse

Clinical
Relapse

Monitoring MRD at various points throughout the course of treatment and remission provides important insight into the status of a patient’s disease in lymphoid malignancies like myeloma and acute lymphoblastic leukemia.[1-5]

HOW IS MRD MEASURED?

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Lurking cancer cells may go undetected.

CONVENTIONAL DETECTION

Clinicians have been evaluating residual disease in lymphoid cancers for decades, but historically, MRD assessment lacked the precision and sensitivity to identify and track disease at the low levels where disease often lurks.[6]

Among conventional MRD detection methods, no single test offered the deepest levels of sensitivity, an accurate quantification of disease burden, and the standardization necessary to provide clinicians with confidence in the results.[6]

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Cancer cells that may have been missed can now be detected.

ENHANCED DETECTION

Recent advancements in MRD testing, driven by development of the clonoSEQ® Assay, have enabled precise identification and quantitation of the specific DNA sequences associated with lymphoid malignancy, empowering clinicians to accurately and reliably assess a patient’s MRD status at any point during treatment or remission.[7-9]

WHY MEASURE MRD?

Accurate MRD assessment can guide clinicians in developing personalized treatment approaches

The enhanced ability to monitor MRD has the potential to inform patient management decisions in several important ways:

MRD assessment can help predict clinical outcomes

Given the nature of current therapies, some patients will achieve remission of their disease while others ultimately relapse.[8] The goal of utilizing MRD in patient management is to be able to detect residual disease at the lowest level possible in order to be confident in a patient’s MRD status. Data demonstrates that deep MRD negativity correlates with improved outcomes. As a result, clinicians can use MRD test results to assess a patient’s response to treatment, which may inform decisions made throughout the treatment continuum.[7]

MRD enables for early detection of relapse

Quantitative MRD assessment may identify progression of disease much sooner than the onset of physical signs and symptoms. The more sensitive the MRD detection assay, the sooner impending relapse can be identified.[8] This “lead time” gained by not waiting until physical signs and symptoms emerge may allow a clinician to intervene earlier to regain control of a patient’s disease.[10]

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Deep sensitivity enables early detection of relapse, allowing for possible early intervention.[10]

THE FUTURE OF MRD

MRD is emerging as a key measure of efficacy for new therapies

Drug developers are increasingly leveraging MRD assessment to expedite the approval of innovative therapeutics.[11] The prognostic value of MRD assessment has been demonstrated in multiple diseases, and measurement of residual disease is currently being evaluated as a way to measure efficacy in drug trials, with the potential to expedite the approval of emerging therapies.[7,12]

To date, much of this research has been performed using different assays with varying levels of sensitivity and inconsistent approaches, which has limited the ability to broadly standardize MRD assessment.[6]


For results to be considered reliable and broadly applicable, an MRD assay needs to be:
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Highly Senstive

Widely Available

Compliant with Regulatory Requirements

Reproducible Using Standardized Methods

Capable of Meeting the High Bar for Incorporation in Clinical Trials


Investigators studying multiple hematologic malignancies have found that the clonoSEQ Assay meets these strict requirements and they are turning to clonoSEQ as a standardized approach for MRD detection in clinical trials around the world.[13]


This page is intended for use by healthcare professionals of the United States.

clonoSEQ® is available as a FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect minimal residual disease (MRD) in bone marrow samples from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL). clonoSEQ is also available for use in other lymphoid cancers as a CLIA-regulated laboratory developed test (LDT) service. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.

Citations

  1. Wu D, et al. Clin Cancer Res. 2014;20(17):4540-8.
  2. Korde N, et al. JAMA Oncol. 2015;1(6):746-54.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed March 11th, 2020. To view the most recent and complete version of the guideline, go to NCCN.org.
  4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed March 11th, 2020. To view the most recent and complete version of the guideline, go to NCCN.org.
  5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed March 11th, 2020. To view the most recent and complete version of the guideline, go to NCCN.org.
  6. Sherrod AM, et al. Bone Marrow Transplant. 2015;51:2-12.
  7. clonoSEQ®. https://clonoseq.com/technical-summary. Seattle, WA: Adaptive Biotechnologies; 2018.
  8. Pulsipher M, et al. Blood. 2015;125(22):3501-8.
  9. Martinez-Lopez J, et al. Blood. 2014;123(20):3073-3079.
  10. Logan AC, et al. Biol Blood Marrow Transplant. 2014;20(9):1307-13.
  11. U.S. Food and Drug Administration. (2014). Blinatumomab [Press Release].
  12. Avet-Loiseau H. Am Soc Clin Oncol Educ Book. 2016; 35:e425-30.
  13. ClinicalTrials.gov. Search: clonoSEQ. Accessed May 5, 2020.