Adaptive Highlights NCCN Myeloma Guideline Updates Naming clonoSEQ

Adaptive Biotechnologies Corporation (ADPT ) announced on September 17, 2026, that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for Multiple Myeloma, adding for the first time a dedicated page outlining principles of minimal residual disease (MRD) testing that specifically references the company’s clonoSEQ assay.

The Seattle-based commercial-stage biotechnology company said the new page, designated MYEL-E, brings MRD testing recommendations together in one place and gives clinicians a clearer, more consistent approach to using MRD testing in patients. According to Adaptive, the update builds on years of clinical evidence demonstrating that MRD negativity is associated with longer progression-free survival and overall survival, and it may help support more informed conversations between patients and their care teams about disease status, treatment decisions, and ongoing monitoring. NCCN maintains and publishes the Multiple Myeloma guideline within its Treatment by Cancer Type guidelines library.

Updated Testing Recommendations

According to Adaptive’s description of the updated guidelines, bone marrow-based MRD assessment is recommended using next-generation sequencing (NGS) with an FDA-approved assay such as clonoSEQ, or multicolor flow cytometry. The company noted that clonoSEQ is the only assay specifically named in the NCCN Guidelines.

Per the company, the updated recommendations state 10⁻⁶ as the preferred sensitivity for MRD testing due to its higher prognostic value, with 10⁻⁵ described as the minimum recommended sensitivity. Recommended timepoints for MRD assessment were expanded to include annual testing during maintenance therapy and after later lines of therapy, including after CAR T-cell therapy, a change Adaptive said reinforces the role of MRD as a longitudinal measure of disease status.

The guidelines also address how MRD results can inform care, according to the company. 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, while 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, said the updated guidelines represent an important step forward in how MRD is used 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,” he said. Landgren also said MRD should be followed over time, that sustained MRD negativity is more informative than a single negative result, and that 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.

Susan Bobulsky, Chief Commercial Officer, MRD, at Adaptive Biotechnologies, said 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. She said 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. “These updates underscore clonoSEQ’s established leadership in hematology MRD testing and reflect the continued evolution of the field toward MRD-informed patient care,” she said.

clonoSEQ Clearance and Coverage

According to the company, clonoSEQ is the first and only FDA-cleared in vitro diagnostic test for detecting and tracking MRD in patients with multiple myeloma or B-cell acute lymphoblastic leukemia using bone marrow, and in patients with chronic lymphocytic leukemia using blood or bone marrow. The test is also available in diffuse large B-cell lymphoma, mantle cell lymphoma, and other lymphoid cancers and specimen types as a CLIA-validated laboratory-developed test. Adaptive said clonoSEQ is covered by Medicare for multiple myeloma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, diffuse large B-cell lymphoma, and mantle cell lymphoma.

The company states that clonoSEQ identifies and quantifies DNA sequences in malignant cells, detecting one cancer cell in one million healthy cells, and that the assay has been studied in more than 300 peer-reviewed publications. clonoSEQ is CE-marked under the EU In Vitro Diagnostic Regulation, according to Adaptive.

Adaptive describes itself as a commercial-stage biotechnology company focused on translating the genetics of the adaptive immune system into clinical products to diagnose and treat disease. The company applies its proprietary immune medicine platform across two business areas, Minimal Residual Disease and Immune Medicine, and said it uses the platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics for diseases including cancer, autoimmune disorders, and infectious diseases.