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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

clonoSEQ Technical Summary clonoSEQ REPORT OVERVIEW

What makes clonoSEQ unique

clonoSEQ technical innovations

Somatic Hypermutation

Ability to Handle SHM

Assay Design Increases Resilience to Somatic Hypermutation (SHM)

Accounts for naturally occurring changes in MRD markers.1,2

Step-by-step process icon

Avoidance of False Negatives*

Synthetic Immune Repertoire Provides Step-by-Step Process Controls

Provides confidence in clonoSEQ MRD results.2

DNA sequences

Sophisticated Bioinformatics

Expert-developed Algorithms Maximize Assay Accuracy

Generates clinically meaningful outputs from complex datasets.1,2

Magnifying glass looking at a blood sample

Minimal Sample Volumes

Assay Design Enables Sensitivity with Minimal Sample Volumes

Enables efficient and consistent evaluation of all B-cell receptor loci.1,2

Identification of multiple malignant clones

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

Why MRD assessment?

*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.


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.