Now FDA-cleared for CLL, Multiple Myeloma, and B-ALL
Monitor residual disease with clonoSEQ, FDA-cleared for MRD assessment in bone marrow from patients with multiple myeloma or B-ALL and blood or bone marrow from patients with CLL. clonoSEQ is covered by Medicare for patients with CLL, B-ALL or multiple myeloma. View the Technical Summary.
Data with depth.
Results with relevance.®
Ultra-sensitive MRD Detection
The FDA-cleared clonoSEQ® Assay is a highly sensitive, specific, and standardized method for detecting and monitoring MRD, or measurable residual disease, in patients with multiple myeloma, B-cell acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL).[1,2] MRD refers to the small number of cancer cells that can remain in a patient’s body after treatment and may eventually cause recurrence of the disease.
clonoSEQ leverages the power of next-generation sequencing (NGS) and offers an accurate and reliable way to assess how disease burden changes over time in response to treatment or during remission.[1,2]
clonoSEQ is the first and only MRD assay to receive FDA-clearance for detection and monitoring of residual disease in bone marrow from patients with multiple myeloma or B-ALL, or blood and bone marrow from patients with CLL.
clonoSEQ can help clinicians:
Incorporate clonoSEQ testing into your clinical practice
Clinicians at leading institutions around the world are already using clonoSEQ to help assess and manage their patients with lymphoid malignancies like multiple myeloma, B-cell ALL, and CLL.
Explore the value of the clonoSEQ Assay by reviewing our patient case studies:VIEW PATIENT CASES
Meaningful advantages of the clonoSEQ Assay for residual disease detection and monitoring
The clonoSEQ Assay leverages the power of immunosequencing coupled with groundbreaking advances in chemistry and proprietary bioinformatics to assess the presence of malignant cells at levels below the detection limit of conventional cytomorphological methods.[2,3] When a sufficient sample is provided, the assay can routinely identify the presence of one cancer cell in a sample of 1 million healthy cells.[1,2]
clonoSEQ is the first next-generation sequencing (NGS MRD test) to receive clearance by the FDA. The FDA first reviewed the clonoSEQ Assay through the De Novo premarket review process, a regulatory pathway for novel devices and tests that are not substantially equivalent to an existing commercial product. FDA clearance of additional indications was granted under the 510(k) pathway.
Selecting clonoSEQ for residual disease testing in myeloma, B-ALL, and CLL means you can be confident that your MRD testing method has achieved the high validation standards established by the FDA. In addition, use of clonoSEQ can facilitate standardized MRD assessment in myeloma, ALL, and CLL clinical trials. Drug developers perceive clonoSEQ as a powerful tool for MRD assessment due to the sensitivity, specificity, and standardization that our NGS platform provides.
clonoSEQ detects measurable residual disease (MRD) at the level of a single cancer cell among a million cells, given sufficient sample input. The assay provides a continuous measure of MRD, with its sensitivity limited only by the amount of DNA analyzed. Measuring MRD at such low levels offers prognostic value to clinicians as they assess how patients respond to treatment.[1,2]
clonoSEQ enables identification and tracking of individual cancer cells. Once the DNA sequences associated with these cancer cells are identified, the presence of each specific sequence can be assessed in subsequent MRD samples, enabling clinicians to gain a more precise understanding of disease burden over time.[1,2]
clonoSEQ has undergone extensive analytical and clinical validation, fulfilling requirements for FDA clearance for in vitro diagnostic use.[1,2] The consistency demonstrated across these validation studies meets the high bar for standardization required by cooperative research groups and drug developers, while also enhancing patient management in the clinic.
What gets measured gets managed®
clonoSEQ detects residual disease by identifying the individual DNA sequences associated with lymphoid cancers. Once identified in a high disease load diagnostic or relapse sample, these sequences can be tracked over time, allowing clinicians to monitor the patient’s disease status in follow-up samples throughout the course of treatment and during remission.
clonoSEQ provides more than a binary (yes/no) assessment of the presence of disease. The assay quantifies residual disease, tracks the identified sequences over time, and monitors for the emergence of new sequences, which may signal disease evolution or recurrence. The deep sensitivity of the clonoSEQ Assay has been shown to help predict patient outcomes and add insight to the evaluation of disease response to therapy, enabling timely decisions about how and when to intervene.
CONFIDENTLY MONITOR RESPONSE
DETECT POTENTIAL RELAPSE
MRD testing is recommended by clinical practice guidelines
MRD assessment is recognized as an essential metric to inform and enhance treatment decisions throughout treatment in a growing number of lymphoid malignancies.[4-7] International clinical practice guidelines recommend assessing MRD at multiple time points during treatment and maintenance in CLL, multiple myeloma, and B-ALL, and include NGS as a testing method option.[4-7]
Adaptive is committed to helping you apply the power of highly advanced and ultra sensitive MRD detection and monitoring in your practice. With positive private payer coverage decisions in addition to Medicare coverage, access to clonoSEQ has expanded to over 200 million people.
Learn more about how to order the clonoSEQ Assay.
NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) incorporate MRD testing as a Category 2A recommendation for myeloma patients.
NCCN Guidelines® incorporate MRD testing as a Category 2A recommendation for patients with ALL.[5,6]
This page is intended for use by healthcare professionals of the United States.
clonoSEQ® is available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect measurable residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ is also available for use in other lymphoid cancers as a CLIA-validated laboratory developed test (LDT) service. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.
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- clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020. https://clonoseq.com/technical-summary.
- Ching T, et al. BMC Cancer. 2020;20:612.
- Sherrod A, et al. Bone Marrow Transplant. 2015;51:2-12.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed March 11th, 2020. To view the most recent and complete version of the guideline, go to NCCN.org.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Acute Lymphoblastic Leukemia V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed March 11th, 2020. To view the most recent and complete version of the guideline, go to NCCN.org.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed March 11th, 2020. To view the most recent and complete version of the guideline, go to NCCN.org.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia V.4.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed [July 1, 2020]. To view the most recent and complete version of the guideline, go online to NCCN.org.
*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.