Technology
An innovative NGS platform powering clinical MRD assessment
clonoSEQ® 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
Minimal Sample Volumes
Assay Design Enables 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 Clone Identification Rates
Makes clonoSEQ applicable to broad populations of patients with B-cell malignancies.1,2
*False-positive or false-negative results may occur for reasons including, but not limited to: contamination; technical and/or biological factors, such as the type of rearrangement or the size of the junction region.
Technical platform
Advances in sequencing, chemistry, and bioinformatics
clonoSEQ 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.1-3
NGS enables differentiation of very small numbers of remaining malignant cells against a background of millions of normal cells.1,2,4
Advances in tracking clonal progression over time
clonoSEQ leverages proprietary innovations to not only track sequences that are identified at diagnosis as markers of disease, but to also detect newly emerging clonal sequences over time.1,2,5
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
†T-cell testing is available as CLIA-validated LDT and has not been cleared or approved by the FDA.
Multiple myeloma experience and data
CLL experience and data
Pediatric ALL experience and data
Adult ALL experience and data
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). CLL Clonality (ID) Tests will also produce an IGHV status result, which is provided as a CLIA-validated laboratory developed test (LDT) but which has not been cleared or approved by the FDA. Additionally, clonoSEQ is available for use in other lymphoid cancers and specimen types as a CLIA-validated LDT. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.
References
- Ching T, et al. BMC Cancer. 2020;20:612.
- clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020. https://clonoseq.com/technical-summary
- 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.