An innovative NGS platform powering clinical MRD assessment

Advances in sequencing, chemistry, and bioinformatics

The clonoSEQ® Assay is powered by next-generation sequencing (NGS) technology and differentiated from other NGS assays by groundbreaking advances in chemistry and proprietary bioinformatics.[1] Together, these discoveries translate into unique advantages for clinicians and patients, providing powerful new insights into disease burden from diagnosis through treatment and survivorship.

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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]

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]

In the context of residual disease assessment, NGS is a tool that enables differentiation of very small numbers of remaining malignant cells against a background of millions of normal cells. That’s why NGS is able to be a powerful approach for monitoring MRD.[1]

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Advantages in chemistry

clonoSEQ leverages proprietary innovations to solve the problem of PCR amplification bias.[1]

The solution is a library of synthetic molecules that mimic the complete set of V and J genes on the CDR3 region of lymphocytes. This “synthetic immune system” enables clonoSEQ to analyze the entire immune repertoire, every time the test is used.[1]

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.[3]

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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.[4]

Behind the scenes, these algorithms are the computational workhorses of the clonoSEQ Assay. They correct residual amplification bias, detect and adjust for mutations that occur in tracked sequences over time, evaluate sequence uniqueness to inform selection of the appropriate clones to track, and determine the assay’s limit of detection and quantitation based on input sample material.[1,4]


This page is intended for use by healthcare professionals of the United States.

clonoSEQ® is available as a FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect minimal residual disease (MRD) in bone marrow samples from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL). clonoSEQ is also available for use in other lymphoid cancers as a CLIA-regulated laboratory developed test (LDT) service. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.

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Citations

  1. clonoSEQ®. https://clonoseq.com/technical-summary. Seattle, WA: Adaptive Biotechnologies; 2018.
  2. Reuter J, et al. Mol Cell. 2015;58(4):586-97.
  3. Kirsch I, et al. Molec Oncol. 2015;9(10):2063-70.
  4. Data on file. Clinical Study Reports REP-01038 and REP-01041. Seattle, WA; Adaptive Biotechnologies Corp; 2017.