For patients with lymphoid malignancies the presence of measurable residual disease (MRD), even at very low levels, can be clinically meaningful. Because MRD is a direct measure of disease, assessing its presence and level becomes a powerful way to understand risk, evaluate response to treatment, and detect early signs of potential disease recurrence.[1]
However, MRD assessment is complicated by the fact that cancerous B and T cells exist amidst a vast array of normal B and T cells. Finding a malignant cell among the huge number of normal ones is like finding one specific snowflake in a blizzard.
Much like a snowflake, each B or T cell has a specific structure which makes it different from other B or T cells in the adaptive immune system.[2]
These differences among B and T cells stem from rearrangements that occur in the DNA within a specific region of a B- or T-cell receptor called the CDR3 region.[2]
Within this region, there are 3 types of sequences — Variable (V), Diversity (D), and Joining (J) — that recombine with other random DNA sequences to create a novel sequence that uniquely identifies each B- or T-cell receptor.[2]
This process of VDJ rearrangement creates a nearly limitless potential for diversity among B- and T-cell populations.[3] The diversity of each individual’s B- and T-cell receptors is what enables a powerful immune response to a wide array of pathogens.
See how the unique biology of B-cell and T-cell receptors enables identification and tracking of individual lymphocytes.
Built on the foundational innovations of Adaptive Biotechnologies’ proprietary immunosequencing platform, the clonoSEQ® Assay is designed to address these needs.[1]
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 deliver powerful insights to clinicians and patients.[1]
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The clonoSEQ Assay sets itself apart from other MRD assays through a series of innovations that are critical to its value in the clinic.
Assay Design Increases Resilience to Somatic Hypermutation (SHM)
Corrects for naturally-occurring changes in MRD markers.
Somatic hypermutation (SHM) can cause clinical assays to underestimate MRD or even miss it entirely. The clonoSEQ Assay is engineered to minimize the impact of SHM on clonoSEQ MRD results.[4,5]
Synthetic Immune Repertoire Provides Step-by-step Process Controls
Provides confidence in clonoSEQ MRD results.
Each distinct step in the clonoSEQ Assay is monitored by a corresponding control molecule. That’s why when clonoSEQ produces an MRD-negative result, it is clear to a clinician that the test output is accurate and not the result of an assay failure.[1]
Expert-developed Algorithms Maximize Assay Sensitivity and Accuracy
Generates clinically meaningful outputs from complex datasets.
The algorithms that are used to transform raw sequencing data into clonoSEQ results are designed to maximize the assay’s ability to distinguish signal vs. noise and to optimally translate raw sequencing reads into contextualized information for clinical use.[1]
Built-in Synthetic Immune Repertoire Helps Solve for Amplification Bias
Makes clonoSEQ results quantitative and clinically relevant.
clonoSEQ is the first MRD assay to leverage a synthetic immune repertoire to address the inherent bias that occurs when DNA sequences are amplified using multiplex PCR. These synthetic molecules enable highly accurate and reproducible quantitation of residual disease.[1,6,7]
Precise Measurement of “MRD Denominator” Maximizes Accuracy of Results
Contextualizes clonoSEQ MRD results.
clonoSEQ uses a robust internal measure to quantify the total nucleated cells (i.e. input DNA) contained in a tested sample. The use of this internal measure ensures the accuracy of a value which is critical to the interpretation of a clinical MRD result.[1]
Single Tube Design Enables High Sensitivity with Minimal Sample Volumes
Enables efficient and consistent evaluation of all B-cell receptor loci.
By evaluating all B-cell receptor loci together in a single PCR reaction, the clonoSEQ Assay conserves sample material, enabling maximum sensitivity to be achieved with minimal sample material.[1]
Coverage of all Relevant Loci Enables High Malignant Clones Identification Rates
Makes clonoSEQ applicable to broad populations of patients with B-cell malignancies.
With the inclusion of primer sets for IGH, IGK, and IGL, as well as IGH-BCL1 / IGH-BCL2 translocations, the clonoSEQ Assay provides a comprehensive assessment of immune receptors in a single assay for patients with B-cell malignancies.[1]
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 dxsupport@adaptivebiotech.com.
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