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About clonoSEQ

Leading cancer centers use clonoSEQ® in routine clinical practice

clonoSEQ is a next-generation sequencing test

FDA-cleared for monitoring minimal residual disease (MRD) in chronic lymphocytic leukemia (CLL), multiple myeloma, and B-cell acute lymphoblastic leukemia (ALL).

clonoSEQ HCP BROCHURE

State-of-the-art residual disease assessment

The challenge of residual disease detection: finding the few among the many

For patients with lymphoid malignancies, the presence of 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.[1,2]

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.

Sensitivity

clonoSEQ detects MRD at the level of a single cancer cell among a million cells, given sufficient sample input. The assay provides a continuous measure of MRD, with its sensitivity limited only by the amount of DNA analyzed. Measuring MRD at such low levels offers prognostic value to clinicians as they assess how patients respond to treatment.[1,2]

Specificity

clonoSEQ enables identification and tracking of individual cancer cells. Once the DNA sequences associated with these cancer cells are identified, the presence of each specific sequence can be assessed in subsequent MRD samples, enabling clinicians to gain a more precise understanding of disease burden over time.[1,2]

Standardization

clonoSEQ has undergone extensive analytical and clinical validation, fulfilling requirements for FDA clearance for in vitro diagnostic use.[1,2] The consistency demonstrated across these validation studies meets the high bar for standardization required by cooperative research groups and drug developers, while also enhancing patient management in the clinic.

How clonoSEQ works

The Adaptive Immune System

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.[3]

These differences among B and T cells stem from rearrangements that occur in the DNA within a specific region that codes for the B- or T-cell receptor called the CDR3 region.[3]

Within this region, there are 3 types of segments — 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.[3]

This process of VDJ rearrangement creates a nearly limitless potential for diversity among B- and T-cell populations.[4] The diversity of each individual’s B- and T-cell receptors is what enables a powerful immune response to a wide array of pathogens.

When a B or T cell becomes malignant, the DNA that encodes the CDR3 region of that lymphocyte serves as a precise and unique marker of the malignancy.[3]

That marker remains useful as a means to identify disease and quantify disease burden over the course of a patient’s treatment journey.[3]

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The Power of Immunosequencing

See how the unique biology of B-cell and T-cell receptors enables identification and tracking of individual lymphocytes


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). Additionally, clonoSEQ is available for use in other lymphoid cancers and specimen types as a CLIA validated laboratory developed test (LDT). IGHV testing is available as a CLIA-validated LDT and has not been cleared or approved by the FDA. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.

*T-cell testing is available as CLIA-validated LDT and has not been cleared or approved by the FDA.

Citations

  • Kirsch I, et al. Molec Oncol. 2015;9(10):2063-2070.
  • Abbas A, et al. Cell and Molec Immuno. Philadelphia, PA: Elsevier. 2015:176-177.