The First and Only FDA-cleared Assay for Measurable Residual Disease Detection
MRD detection in bone marrow from patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL).
MRD: A powerful way to assess response
and predict patient outcomes
Measurable (or minimal) residual disease (MRD) refers to the small number of cancer cells that may remain in a patient’s body during and after treatment. Clinical practice guidelines recognize that MRD status is a reliable indicator of clinical outcome and response to therapy in myeloma, ALL and CLL patients.1,2,3,4
The clonoSEQ® Assay is an MRD assessment tool powered by next-generation sequencing (NGS) technology and differentiated from other NGS assays by groundbreaking advances in chemistry and proprietary bioinformatics.5,6
Clinicians who leverage the latest advances in
personalized medicine use clonoSEQ to:5
Predict
long-term outcomes
Assess
treatment response
Monitor
disease burden
Detect
potential relapse
Why choose clonoSEQ?5, 6
Deep Sensitivity
Able to detect one cancerous cell in 1 million normal cells*
Broad patient experience
>15,000 patients tested to date
Reliable results
First and only FDA-cleared MRD assay; demonstrates accuracy, precision, and reproducibility
Widely utilized by experts
30 out of 30 NCCN institutions currently using in clinical trials and/or clinical practice
Streamlined ordering
Samples collected will be sent to Adaptive Biotechnologies for testing. clonoSEQ will be performed, reported, and billed by Adaptive. Labcorp insurance contracts do not apply. Adaptive Biotechnologies and Labcorp are independent providers.
NCCN Guidelines
NGS MRD testing incorporated in NCCN guidelines for myeloma, ALL and CLL1,2,3,4
How clonoSEQ Works5
Clonality (ID) Test
Identifies trackable malignant DNA sequence(s) in a high disease load sample collected at the time of diagnosis or relapse
Tracking (MRD) Test
Quantifies and tracks MRD during or after treatment in a freshly-drawn bone marrow or blood sample
*With sufficient input material
clonoSEQ is available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect minimal 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 and specimen types as a CLIA-validated laboratory developed test (LDT). For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.
Resources
Samples collected will be sent to Adaptive Biotechnologies® for testing. clonoSEQ will be performed, reported and billed by Adaptive Biotechnologies. Labcorp insurance contracts do not apply. Adaptive Biotechnologies and Labcorp are independent providers. For more information, visit www.clonoseq.com.
* 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.
1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.2.2020. © National Comprehensive
Cancer Network, Inc. 2020. All rights reserved. Accessed November 20, 2020. To view the most recent and complete version of the guideline, go to NCCN.org.*
2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Acute Lymphoblastic Leukemia V.2.2021. © National
Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed November 20, 2020. To view the most recent and complete version of the guideline, go to NCCN.org.*
3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.1.2021. © National Comprehensive Cancer
Network, Inc. 2021. All rights reserved. Accessed November 20, 2020. To view the most recent and complete version of the guideline, go to NCCN.org.*
4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma V.1.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed November 20, 2020. To view the most recent and complete
version of the guideline, go to NCCN.org.*
5. clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies Corporation; 2020.
6. Ching T, et al. BMC Cancer. 2020;20:612.