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.
An emerging tool for guiding clinical decisions
clonoSEQ is covered by Medicare and many commercial payers, utilized in routine clinical practice by top-tier institutions, and incorporated into pivotal therapeutic trials.
Adaptive’s mission is to translate immunosequencing discoveries into clinical diagnostics and therapeutics to improve patient care.
LEARN MORE ABOUT ADAPTIVE'S HISTORY
Founded in 2009
Adaptive operates a CLIA-certified, CAP-accredited and ISO 13485-certified laboratory in Seattle, WA
Headquarters: Seattle
3 locations, 500+ employees
What is immunosequencing
The human body is constantly attacked by hundreds of external pathogens. Our adaptive immune system is constantly monitoring these invaders, keeping a record of each agent or pathogen our immune cells (B and T cells) encounter.
Adaptive Biotechnologies uses next-generation sequencing (NGS), also known as high-throughput sequencing (HTS) which enables simultaneous identification of millions of unique B and T-cell receptors, from a single patient sample.
Immunosequencing can be a powerful tool for aiding patient management in conditions where lymphocytes play a role including lymphoid malignancies.
Measurable Residual Disease (MRD) is the disease
In hematologic cancers, minimal or measurable residual disease (MRD), refers to the number of cancer cells that may remain in the body of a patient during and after treatment. These small traces of disease don’t typically cause physical signs or symptoms, but can cause a patient to relapse.
These lurking malignant cells can be present at levels undetectable by traditional morphological assessment.[1]
Physicians need advanced, accurate, and sensitive tools to precisely and reliably identify MRD at levels that may exist below the limits of conventional assessment tools.
CONVENTIONAL DETECTION
Lurking cancer cells may go undetected
ENHANCED DETECTION
Cancer cells that may have been missed can now be detected
Why does MRD matter in lymphoid malignancies?
Assessment of tumor burden during initial staging and throughout treatment has been a basic concept in oncology for as long as cancer has been recognized and treated by the medical community. Knowledge of the extent of a patient’s disease, if and how the malignancy is responding to therapy, and whether or not cancerous cells remain that may cause recurrence is fundamental to patient management.[2-5]
The assessment of MRD applied to hematopoietic malignancies is simply a variation on the theme of this critical definition of tumor burden assessed over the course of therapy of a patient.
In the context of lymphoid cancers, MRD refers to the presence of malignant B or T cells that may remain in a patient’s body during and following treatment.
MRD is a direct measure of disease; so measuring MRD is a powerful tool to help understand potential patient outcomes, evaluate response to therapy, and monitor disease during remission.[6] An extensive literature base, including recent large meta-analyses, supports the value of MRD assessment in lymphoid cancers.[7-10]
MRD assessment points during the course of treatment of lymphoid cancers [2-5]
MRD assessment is recommended in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for several hematologic malignancies* [2-5]
With the emergence of more highly effective and targeted therapies in hematologic malignancies, physicians and patients need accurate and sensitive tools to measure deep and durable levels of response in a standardized and reliable way.
The clonoSEQ Assay: sensitive, accurate, and standardized MRD detection for patients with lymphoid malignancies
The clonoSEQ Assay provides patients, physicians and payers with a sensitive, accurate, and standardized method for MRD detection, by leveraging the power of next-generation sequencing.
500+
physicians ordering clonoSEQ
>12,300
unique patients tested to date
>65
peer-reviewed publications*
>70
ongoing prospective trials
30 of 30
National Comprehensive Cancer Network® (NCCN®) member institutions use clonoSEQ
*Results generated on a research version of the clonoSEQ Assay.
SENSITIVITY
clonoSEQ detects measurable residual disease at the level of a single cancer cell among a million cells. Measuring MRD at such low levels offers prognostic value to clinicians as they assess how patients respond to treatment.[6,11]
SPECIFICITY
clonoSEQ enables identification and tracking of individual cancer cells. Just as fingerprints track and provide specific information about one’s identity, clonoSEQ can scan a sample looking for malignant sequences to track over time.[6,11]
STANDARDIZATION
clonoSEQ has undergone extensive analytical and clinical validation, which is critical when using MRD results to inform patient management.[6,11]
Why choose clonoSEQ?
clonoSEQ is supported by a broad and deep evidence base with more studies ongoing. Check back for updates.
ANALYTICAL VALIDATION
Review key findings from 11 analytical validation studies demonstrating the performance characteristics of the clonoSEQ Assay.[6,11]
CLINICAL VALIDATION
Learn more about the data demonstrating the clinical validity of clonoSEQ in multiple myeloma, acute lymphoblastic leukemia, and chronic lymphocytic leukemia.
CLINICAL UTILITY
For more information about the clinical utility of the clonoSEQ Assay, contact the clonoSEQ Payer Team.
CREDENTIALING MATERIALS
Get the credentialing details for the clonoSEQ Assay.
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.
Clinical Data Summaries
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Citations
- Bal S, et al. Br J Haematol. 2019;186(6):807-819.
- 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 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 Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia V.4.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed [February 19, 2020]. To view the most recent and complete version of the guideline, go online to NCCN.org.
- clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020. https://clonoseq.com/technical-summary.
- Munshi N, et al. JAMA Oncology. 2016;3(1):28-35.
- Landgren O, et al. Bone Marrow Transplant. 2016;51(12):1565-1568.
- Berry D, et al. JAMA Oncology. 2017. doi:10.1001/jamaoncol.2017.0580.
- Molica S, et al. Clin Lymphoma Myeloma Leuk. 2019;19(7):423-430.
- Ching T, et al. BMC Cancer. 2020;20:612.
*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.