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. Together, these discoveries translate into unique advantages for clinicians and patients, providing powerful new insights into disease burden from diagnosis through treatment and survivorship.
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.
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.
Advantages in chemistry
clonoSEQ leverages proprietary innovations to solve the problem of PCR amplification bias.
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.
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.
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.
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 outside of the United States.
The clonoSEQ Assay B-cell Reagent Set is an in vitro diagnostic that identifies and quantifies rearranged B-cell receptor gene sequences in DNA extracted from blood and bone marrow.
It is a manual test that determines measurable/minimal residual disease (MRD) and monitors changes in disease burden during and after treatment in B-cell malignancies. The test is indicated for use by qualified healthcare professionals for clinical decision-making and in conjunction with other clinicopathological features.
The clonoSEQ Assay is being utilized for a variety of investigator-sponsored clinical trials in B-cell lymphoid cancers. If you are interested in learning more about use of clonoSEQ in your own trials, contact email@example.com.
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- The clonoSEQ Assay B-Cell Reagent Set is CE marked as in vitro diagnostic (IVD) for assessing the MRD status and changes in disease burden during and after treatment in B-Cell malignancies in DNA extracted from blood and/or bone marrow samples.
- Reuter J, et al. Mol Cell. 2015;58(4):586-97.
- Kirsch I, et al. Molec Oncol. 2015;9(10):2063-70.
- Data on file. Clinical Study Reports REP-01038 and REP-01041. Seattle, WA; Adaptive Biotechnologies Corp; 2017.