Technology
An innovative NGS platform powering clinical MRD assessment
The clonoSEQ® Assay sets itself apart from other MRD assays through a series of innovations that are critical to its value in the clinic
What makes clonoSEQ unique
clonoSEQ technical innovations
Ability to Handle SHM
Assay Design Increases Resilience to Somatic Hypermutation (SHM)
Accounts for naturally-occurring changes in MRD markers.[1,2]
Avoidance of False Negatives
Synthetic Immune Repertoire Provides Step-by-Step Process Controls
Provides confidence in clonoSEQ MRD results.[2]
Sophisticated Bioinformatics
Expert-developed Algorithms Maximize Assay Accuracy
Generates clinically meaningful outputs from complex datasets.[1,2]
Advanced Bias Control
Built-in Synthetic Immune Repertoire Helps Solve for Amplification Bias
Makes clonoSEQ results quantitative and clinically relevant.[2-4]
Enhanced Quantitation
Precise Measurement of “MRD Denominator” Maximizes Accuracy of Results
Contextualizes clonoSEQ MRD results.[1,2]
Minimal Sample Volumes
Single Tube Design Enables High Sensitivity with Minimal Sample Volumes
Enables efficient and consistent evaluation of all B-cell receptor loci.[1,2]
Increased ID Success Rates
Coverage of Relevant Loci Enables High Malignant Clones Identification Rates
Makes clonoSEQ applicable to broad populations of patients with B-cell malignancies.[1,2]
Technical platform
Advances in sequencing, chemistry, and bioinformatics
The clonoSEQ Assay is differentiated from other NGS assays by groundbreaking advances in chemistry and proprietary bioinformatics.[1,2] Together, these discoveries translate into unique advantages for clinicians and patients.
Next-generation sequencing
NGS is an advance in DNA sequencing technology that enables simultaneous identification of millions of unique B-cell and T-cell receptors from a single sample.[1,2,5]
Because of its scale, high speed, and low cost, NGS makes it possible and clinically practical to characterize a tremendous breadth of genetic information at high throughput.[1,2,6]
NGS enables differentiation of very small numbers of remaining malignant cells against a background of millions of normal cells.[1,2]
Advantages in chemistry
clonoSEQ leverages proprietary innovations to solve the problem of PCR amplification bias.[1,2]
The solution is a library of synthetic molecules that enables clonoSEQ to analyze the entire immune repertoire, every time the test is used.[1,2]
That’s why clonoSEQ not only tracks sequences that are identified at diagnosis as markers of disease at diagnosis, but can also detect newly emerging clonal sequences over time.[7]
Advances in bioinformatics
The outputs of NGS are millions of raw sequencing reads. To distill all this data into MRD results that are clinically meaningful and easy to understand, clonoSEQ uses a series of proprietary algorithms that were developed based on the analysis of billions of sequences.[1,2]
CLL data and guidelines
Multiple myeloma data and guidelines
Pediatric ALL data and guidelines
Adult ALL data and guidelines
This page is intended for a US-based audience.
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). Additionally, clonoSEQ is available for use in other lymphoid cancers and specimen types as a CLIA validated laboratory developed test (LDT). IGHV testing is available as a CLIA-validated LDT and has not been cleared or approved by the FDA. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.
Citations
- Ching T, et al. BMC Cancer. 2020;20:612.
- clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020. https://clonoseq.com/technical-summary.
- Robins H, et al. Adaptive Biotechnologies Corporation. US patent 9,150,905. October 6, 2015.
- Robins H, et al. Adaptive Biotechnologies Corporation. US patent 9,371,558. June 21, 2016.
- Carlson C, et al. Nat Commun. 2013;4:2680.
- Reuter J, et al. Mol Cell. 2015;58(4):586-597.
- Kirsch I, et al. Molec Oncol. 2015;9(10):2063-2070.