NCCN guidelines name clonoSEQ for myeloma MRD testing

Adaptive Biotechnologies has announced that the National Comprehensive Cancer Network has updated its clinical practice guidelines for multiple myeloma to introduce a dedicated framework for minimal residual disease testing, with the company's clonoSEQ assay named as a preferred FDA-cleared option.

The revised guidelines include a new page, designated MYEL-E, titled Principles of MRD Testing. For the first time, the NCCN brings together its MRD recommendations in a single structured section, giving community and academic oncologists a consolidated reference for when and how to test. The update formalises an approach that the field has been moving towards for several years, grounded in evidence associating MRD negativity with longer progression-free and overall survival.

What the guidelines now say

The guidelines specify that bone marrow-based MRD assessment should use either next-generation sequencing with an FDA-approved assay or multicolour flow cytometry. clonoSEQ, which received FDA clearance as an in vitro diagnostic for myeloma and B-cell acute lymphoblastic leukaemia, is the only assay named by name in the document. The guidelines set 10 to the power of minus six as the preferred sensitivity threshold, citing its superior prognostic value, while designating 10 to the power of minus five as the minimum acceptable level.

Recommended testing timepoints have also been broadened. Annual assessments during maintenance therapy are now included, as is testing following later lines of treatment, among them CAR T-cell therapy. The guidelines further state that sustained MRD negativity can inform decisions on treatment escalation, de-escalation, and whether to discontinue therapy in selected patients, moving the standard towards more individualised management.

Ola Landgren, director of the Sylvester Myeloma Institute at the University of Miami Miller School of Medicine, said the updates reflect a meaningful shift in clinical practice: "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."

Market context and competitive landscape

The explicit naming of clonoSEQ in a major guideline document is commercially significant. Guideline inclusion frequently accelerates adoption in community oncology settings, where clinicians rely on NCCN documents as a primary reference. clonoSEQ already holds Medicare coverage across five haematological malignancies and carries CE marking under the EU IVDR, giving Adaptive Biotechnologies a regulatory position that rivals in the MRD space have not yet matched with an FDA-cleared IVD.

The broader MRD diagnostics market for haematological cancers is growing as clinical evidence accumulates and payers expand coverage criteria. Competing approaches include multicolour flow cytometry, offered by specialist laboratories without a single branded platform, and a number of next-generation sequencing-based laboratory-developed tests. The distinction between an FDA-cleared IVD and an LDT is increasingly relevant as US regulators scrutinise LDT oversight, a dynamic that could further differentiate clonoSEQ's regulatory status from laboratory-developed alternatives.

Adaptive notes that clonoSEQ has been evaluated in more than 300 peer-reviewed publications, a body of evidence that underpins both the guideline inclusion and the company's positioning as the established standard in haematology MRD testing. The next commercial milestone to watch is whether the expanded testing timepoints, particularly annual maintenance and post-CAR T assessment, translate into measurable volume growth in order volumes and reimbursement claims.