NCCN Multiple Myeloma Guidelines Add Dedicated MRD Testing Page, Name clonoSEQ and Set 10-6 as Preferred Sensitivity
核心洞察
NCCN's updated multiple myeloma (搜索) guidelines (version 1.2027) add a dedicated page, MYEL-E, consolidating Principles of MRD Testing for a more consistent clinical approach.
The guidelines set 10-6 as the preferred MRD sensitivity and 10-5 as the minimum, citing the higher prognostic value of deeper assessment.
clonoSEQ (搜索) is the only assay specifically named in the guidelines as an FDA-cleared NGS test for bone marrow-based MRD assessment.
The National Comprehensive Cancer Network (搜索) has updated its Clinical Practice Guidelines in Oncology for multiple myeloma (搜索) to strengthen recommendations for minimal (or measurable) residual disease testing, including a dedicated page outlining Principles of MRD Testing. The update, reflected in guidelines version 1.2027, establishes 10-6 as the preferred sensitivity for MRD assessment and names the clonoSEQ (搜索) assay as an FDA-cleared next-generation sequencing test for this purpose.
A Consolidated Framework for MRD Assessment
For the first time, the guidelines include a dedicated page, MYEL-E, that consolidates the Principles of MRD Testing to give clinicians a more consistent approach to using MRD testing in patients. The update builds on clinical evidence demonstrating that MRD negativity is associated with longer progression-free survival and overall survival. Sustained MRD negativity for 12 months or longer carries a strong correlation with prolonged PFS.
Bone marrow-based MRD can be assessed using NGS with an FDA-approved assay, such as clonoSEQ (搜索), or by multicolor flow cytometry. clonoSEQ is the only assay specifically named in the guidelines.
The minimum recommended sensitivity for MRD testing is 10-5, with 10-6 preferred when possible because it carries higher prognostic value. Recommended timepoints for MRD assessment were expanded to include a baseline sample at diagnosis or before treatment to identify the dominant clonotype for NGS, after induction therapy, after hematopoietic cell transplant or CAR T-cell therapy, at the time of relapse or a substantive treatment change, and at regular intervals during maintenance or surveillance, with annual assessment serving as a general recommendation. Annual testing during maintenance and after later lines of therapy, including after CAR T-cell therapy, reinforces the role of MRD as a longitudinal measure of disease status.
Guiding Treatment Escalation and De-escalation
The updated guidelines note that MRD negativity and sustained MRD negativity can help guide treatment escalation, de-escalation, and maintenance therapy as part of shared decision-making with patients. Rising MRD positivity may prompt, at a minimum, closer monitoring and clinical evaluation.
"Greater sensitivity matters, as it is associated with clinical outcomes, and assessing MRD at a sensitivity of 10-6 gives us a more precise understanding of the depth of response," said Ola Landgren, MD, PhD, director of the Sylvester Myeloma Institute at Sylvester Comprehensive Cancer Center and the University of Miami Miller School of Medicine. "Equally important is the recognition that MRD should be followed over time. Sustained MRD negativity is more informative than a single negative result. Incorporating MRD into decisions about treatment duration, including the possibility of discontinuing therapy in selected patients with sustained MRD negativity, moves the field toward a more individualized approach in which we aim not only to achieve deep responses, but also to avoid unnecessary treatment."
By consolidating MRD testing recommendations in one place, the updated guidelines may support more informed conversations between patients and care teams about disease status, treatment decisions, and ongoing monitoring.
"The updated myeloma guidelines provide more detailed recommendations for MRD testing timepoints and frequency, helping clinicians incorporate MRD assessment into care throughout the myeloma treatment continuum," said Susan Bobulsky, chief commercial officer of MRD at Adaptive Biotechnologies. "These updates underscore clonoSEQ (搜索)'s established leadership in hematology MRD testing and reflect the continued evolution of the field toward MRD-informed patient care."
clonoSEQ's Regulatory and Evidence Base
clonoSEQ (搜索) is the first and only FDA-cleared in vitro diagnostic test for detecting and tracking MRD in patients with multiple myeloma (搜索) or B-cell acute lymphoblastic leukemia (搜索) using bone marrow, and in patients with chronic lymphocytic leukemia (搜索) using blood or bone marrow. The assay is also available in diffuse large B-cell lymphoma (搜索), mantle cell lymphoma (搜索), and other lymphoid cancers and specimen types as a CLIA-validated laboratory-developed test. It is covered by Medicare for multiple myeloma, CLL, ALL, DLBCL and MCL.
The assay identifies and quantifies DNA sequences in malignant cells, detecting one cancer cell in one million healthy cells, to help clinicians and researchers assess and monitor MRD with precision over time. It delivers standardized, sensitive results intended to inform treatment decisions, predict outcomes, and detect relapses earlier. clonoSEQ (搜索) has been studied in more than 300 peer-reviewed publications and is CE-marked under the EU In Vitro Diagnostic Regulation.
NGS-based MRD testing with an FDA-approved assay has been recognized as a surrogate end point for accelerated drug approvals in multiple myeloma (搜索).