NCCN Updates Guidelines to Highlight clonoSEQ for MRD Testing in Multiple Myeloma

Adaptive Biotechnologies has seen a significant update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Multiple Myeloma, which now includes a dedicated framework for routine minimal residual disease (MRD) assessment. This update underscores the importance of MRD testing in modern myeloma management and highlights the role of clonoSEQ® as an FDA-cleared assay for MRD assessment.

The new guidelines, which include a dedicated page titled MYEL-E, provide a clearer and more consistent approach to using MRD testing in patients. This update builds on years of clinical evidence demonstrating that MRD negativity is associated with longer progression-free survival and overall survival. By bringing MRD testing recommendations together in one place, the updated guidelines may help support more informed conversations between patients and their care teams about disease status, treatment decisions, and ongoing monitoring.

The updated guidelines recommend bone marrow-based MRD assessment using next-generation sequencing (NGS) with an FDA-approved assay such as clonoSEQ® or multicolor flow cytometry. Notably, clonoSEQ is the only assay specifically named in the NCCN Guidelines. The guidelines also state that a sensitivity of 10-6 is preferred for MRD testing due to its higher prognostic value, with 10-5 described as the minimum recommended sensitivity.

The guidelines expand the recommended timepoints for MRD assessment to include annual testing during maintenance and after later lines of therapy, including after CAR T-cell therapy. This reinforces the role of MRD as a longitudinal measure of disease status. The updated guidelines reflect the growing clinical utility of MRD assessment in helping clinicians evaluate response to therapy and personalize treatment decisions. MRD negativity and sustained MRD negativity can help guide treatment escalation, de-escalation, and maintenance therapy as part of a shared decision-making process with patients. Conversely, rising MRD positivity may prompt, at a minimum, closer monitoring and clinical evaluation.

Ola Landgren, MD, PhD, director of the Sylvester Myeloma Institute at Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, commented, "The updated NCCN Guidelines represent an important step forward in how we use MRD in multiple myeloma. 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."

Susan Bobulsky, Chief Commercial Officer, MRD, Adaptive Biotechnologies, stated, "NCCN Guidelines play an important role in advancing the standard of care for patients, particularly by helping community oncologists access and apply the latest guidance. 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. These updates underscore clonoSEQ’s established leadership in hematology MRD testing and reflect the continued evolution of the field toward MRD-informed patient care."

The latest NCCN Guidelines can be accessed through the NCCN website. clonoSEQ® is the first and only FDA-cleared in vitro diagnostic (IVD) test for detecting and tracking minimal residual disease (MRD) in patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) using bone marrow, and in patients with chronic lymphocytic leukemia (CLL) using blood or bone marrow. clonoSEQ is also available in diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and other lymphoid cancers and specimen types as a CLIA-validated laboratory-developed test (LDT).