CLLFDA-cleared and CLIA-validated in bone marrow and peripheral blood

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Serial MRD monitoring with clonoSEQ delivers answers during
fixed-duration treatment and beyond

clonoSEQ can help you track disease kinetics

Monitoring MRD with clonoSEQ provides clinically valuable information at multiple stages of CLL care^1-3

Fixed-duration doesn’t mean fixed decisions

Disease kinetics during and after fixed-duration therapy can provide data on disease growth or regression.³

clonoSEQ digs deeper than MFC

At deeper levels, clonoSEQ uncovers more patients with residual disease than MFC⁴

Clinical practice guidelines and clinical trial experience support MRD monitoring at multiple timepoints^1-3,5

	Clinical practice guidelines	Clinical trial experience
During fixed-duration therapy*
End of treatment
Periodically following therapy

FIXED-DURATION
PATHWAY

MRD status is highly prognostic of outcomes following fixed-duration therapy

Patients who were MRD-positive at 10^-5 post treatment had a nearly 7X higher event risk than MRD-negative patients⁶

Different treatment strategies for fixed-duration therapy have been suggested for patients who do not reach uMRD at EoT, including continuation of treatment or treatment intensification.
-Al-Sawaf et al³

NCODA PQI for MRD testing in CLL: A straightforward overview of how to use MRD testing in clinical practice

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Higher Sensitivity and Specificity

clonoSEQ detects disease that MFC cannot

Percentage of patients who were MRD negative by MFC but had residual disease by clonoSEQ

of MFC-negative patients were positive by clonoSEQ at any threshold⁴

of the MFC-negative patients had disease burden detected by clonoSEQ at >10^-4

Even measured at 10^-4, clonoSEQ is a stronger detector of residual disease than MFC⁴

ORDER clonoSEQ

EoT, end of therapy; FCR, fludarabine + cyclophosphamide + rituximab; MFC, multiparameter flow cytometry; OS, overall survival; uMRD, undetectable minimal residual disease.

*MRD following cycles 6 and 9 of fixed duration therapy were protocol-directed measurements from the CLL14 trial.

About the studies

Prognosis and Serial Monitoring
In the phase 3, open-label, randomized CLL14 study, Al-Sawaf et al evaluated rates of undetectable MRD and OS after one-year fixed-duration treatment of Ven-Obi in patients with previously untreated CLL.³

clonoSEQ vs MFC
MRD was assessed using 4-color MFC (10^-4) and clonoSEQ (10^-6) in a total of 124 samples from a study in newly diagnosed CLL patients who received up to 6 courses of standard FCR conducted at the University of Texas MD Anderson Cancer Center (NCT00759798).⁴

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). CLL Clonality (ID) Tests will also produce an IGHV status result, which is provided as a CLIA-validated laboratory developed test (LDT) but which has not been cleared or approved by the FDA. Additionally, clonoSEQ is available for use in other lymphoid cancers and specimen types as a CLIA-validated LDT. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.

References

Al-Sawaf O, et al. Lancet Oncol. 2020;21(9):1188-1200.
Al-Sawaf O, et al. ASH 2020. Abstract 127. https://ash.confex.com/ash/2020/webprogram/Paper136977.html
Al-Sawaf O, et al. J Clin Oncol. 2021;39(36):4049-4060.
Data on file. Adaptive Biotechnologies. 2022.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®️) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.1.2024. ©️ National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed Nov. 20, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020.