Adaptive Biotechnologies Announces Update to NCCN Guidelines® for Multiple Myeloma, Strengthening MRD Testing Recommendations and Specifically Referencing clonoSEQ®
NCCN’s revised multiple myeloma guidelines formalize high-sensitivity MRD testing and specifically reference Adaptive’s FDA-cleared clonoSEQ assay.
Rhea-AI Summary
Adaptive Biotechnologies (ADPT) reports that updated National Comprehensive Cancer Network (NCCN) Guidelines for Multiple Myeloma now provide a dedicated framework for routine minimal (or measurable) residual disease (MRD) assessment, explicitly naming its clonoSEQ assay as an FDA-cleared option. The new MYEL‑E page on Principles of MRD Testing recommends bone marrow MRD assessment using next-generation sequencing with an FDA-approved assay such as clonoSEQ or multicolor flow cytometry.
The guidelines state that MRD sensitivity of 10⁻⁶ is preferred, with 10⁻⁵ as the minimum recommended level. Recommended MRD testing timepoints now include annual assessment during maintenance therapy and testing after later treatment lines, including after CAR T‑cell therapy, emphasizing longitudinal monitoring. The updates highlight that MRD negativity and sustained MRD negativity can inform treatment escalation, de‑escalation, and maintenance decisions, while rising MRD positivity may warrant closer monitoring and clinical evaluation.
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Key Figures
- Preferred MRD sensitivity
- 10⁻⁶
- NCCN Multiple Myeloma guidelines
- Minimum MRD sensitivity
- 10⁻⁵
- NCCN Multiple Myeloma guidelines
Historical Context
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MRD revenue rose 33% and clonoSEQ volume increased 43% in second-quarter results
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Key Terms
minimal residual disease medical
next-generation sequencing technical
in vitro diagnostic medical
laboratory-developed test regulatory
ivdr regulatory
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Updated guidelines establish a dedicated framework for routine MRD assessment across the multiple myeloma patient journey
clonoSEQ named as an FDA-cleared assay for MRD assessment, with 10-6 sensitivity now preferred
SEATTLE, Sept. 17, 2026 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today highlighted significant updates to the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma that further establish highly sensitive minimal (or measurable) residual disease (MRD) assessment as an important tool in myeloma care.
For the first time, NCCN Guidelines® include a dedicated page that outlines Principles of MRD Testing, underscoring the importance of MRD testing in modern myeloma management. The new page, MYEL-E, gives clinicians a clearer, more consistent approach to using MRD testing in patients. The 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.
Significant additions to the NCCN MRD recommendations include:
- Bone marrow-based MRD assessment is recommended 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.
- 10-6 is stated 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 have been expanded to include annual testing during maintenance, and after later lines of therapy including after CAR T-cell therapy, reinforcing the role of MRD as a longitudinal measure of disease status.
Most importantly, the updated guidelines reflect the growing clinical utility of MRD assessment in helping clinicians evaluate response to therapy and personalize treatment decisions. The guidelines note that 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.
“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,” said Ola Landgren, MD, PhD, director of the Sylvester Myeloma Institute at Sylvester Comprehensive Cancer Center, 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.”
“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,” said Susan Bobulsky, Chief Commercial Officer, MRD, Adaptive Biotechnologies. “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 here.
About clonoSEQ
clonoSEQ® is the first and only FDA-cleared in vitro diagnostic (IVD) test for detecting and tracking minimal (or measurable) 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). clonoSEQ is covered by Medicare for MM, CLL, ALL, DLBCL and MCL.
clonoSEQ 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 that inform treatment decisions, predict outcomes, and detect relapses earlier. clonoSEQ has been extensively studied in more than 300 peer-reviewed publications.
clonoSEQ is CE-marked under the EU In Vitro Diagnostic Regulation (IVDR). For intended use details in the EU, see the instructions for use, available on request.
To review the FDA-cleared uses of clonoSEQ, visit clonoSEQ.com/technical-summary.
About Adaptive Biotechnologies
Adaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision, and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.
Forward-Looking Statements
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ADAPTIVE INVESTORS
Karina Calzadilla, Vice President, Investor Relations and FP&A
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investors@adaptivebiotech.com
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FAQ
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How do the updated NCCN Guidelines describe preferred methods for MRD testing in multiple myeloma?
The guidelines recommend bone marrow-based MRD assessment using next-generation sequencing (NGS) with an FDA-approved assay such as clonoSEQ or multicolor flow cytometry. clonoSEQ is the only assay specifically named in the multiple myeloma section.
What MRD sensitivity levels are recommended in the new NCCN multiple myeloma guidelines?
The guidelines state that a sensitivity of 10⁻⁶ is preferred for MRD testing because of its higher prognostic value, while 10⁻⁵ is described as the minimum recommended sensitivity.
At what timepoints do the updated guidelines recommend performing MRD assessments?
Recommended MRD timepoints now include annual testing during maintenance therapy and testing after later lines of therapy, including after CAR T‑cell therapy, to support longitudinal assessment of disease status.
How do the NCCN updates suggest MRD results should be used in treatment decisions?
The guidelines state 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. They also note that rising MRD positivity may prompt closer monitoring and clinical evaluation.
What are some key characteristics of Adaptive’s clonoSEQ assay highlighted in the announcement?
clonoSEQ is described as the first and only FDA-cleared in vitro diagnostic test for detecting and tracking MRD in multiple myeloma and B‑cell acute lymphoblastic leukemia using bone marrow, and in chronic lymphocytic leukemia using blood or bone marrow. It can detect one cancer cell in one million healthy cells, is covered by Medicare for several lymphoid cancers, is available as a CLIA-validated LDT in additional indications, and is CE-marked under the EU In Vitro Diagnostic Regulation.