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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

clonoSEQ Technical Summary

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]

Built-in synthetic immune repertoire

Advanced Bias Control

Built-in Synthetic Immune Repertoire Helps Solve for Amplification Bias

Makes clonoSEQ results quantitative and clinically relevant.[2-4]

3 residual cancer cells amongst over a million total cells

Enhanced Quantitation

Precise Measurement of “MRD Denominator” Maximizes Accuracy of Results

Contextualizes clonoSEQ MRD results.[1,2]

Magnifying glass looking at a blood sample

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]

Identification of multiple malignant clones

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]


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). 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.

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.