B-ALLFDA-cleared in bone marrow, CLIA-validated in peripheral blood
In both pediatric and adult
patients, clonoSEQ provides
convenient
and sensitive
MRD monitoring
Complete response isn’t the complete picture
Though CR is common following initial therapy, most adult and some pediatric patients relapse1-3
Recommended by guidelines
Clinical practice guidelines support MRD monitoring throughout sequential therapy and beyond4,5
Capable and concordant
clonoSEQ detects residual
disease more sensitively
than
MFC, and blood testing provides
comparable
results to marrow6-11
Clinical practice guidelines support MRD monitoring at multiple timepoints4,5
| Pediatric ALL |
Adult ALL |
|
|---|---|---|
| Induction |  |
|
| Transplant | |
|
| Additional timepoints based on the regimen | |
|
| Periodic monitoring for patients with complete molecular remission | |
Higher Accuracy
clonoSEQ detects disease that MFC cannot
Percentage of patients who were MRD negative by MFC but had residual disease by clonoSEQ6,7
Whether used before or after transplant, clonoSEQ more accurately predicted patient outcomes.6,7
clonoSEQ blood testing can complement or potentially replace bone marrow assessment
Concordance between peripheral blood and bone marrow results
83%8
R/R
Pediatric ALL
81%10
Newly diagnosed
Adult ALL
89%9
Adult ALL
patients undergoing
cellular therapies
View real-world case studies that informed care
Dr. Elias Jabbour
MRD Helps Predict Outcomes
and Informs Transplant
Decision
Dr. Jessica Leonard
Initiating Consolidation Prior to Transplant Based on MRD
Positivity
BM, bone marrow; CR, complete response; MFC, multiparameter flow cytometry; R/R, relapsed/refractory.
About the studies
Concordance pediatric ALL
Patients with pediatric relapsed and refractory B-cell ALL were assessed using clonoSEQ. Twenty-four paired blood samples by clonoSEQ and bone marrow samples by MFC were included in the analysis.8
Concordance adult ALL
Two studies assessed 126 and 54 paired bone marrow and peripheral blood samples from 62 and 32 patients with adult ALL.9,10
Adult ALL vs MFC
A retrospective study of 74 Ph-negative ALL patients who achieved a complete remission following frontline therapy. MRD was evaluated by MFC (10-4) and by clonoSEQ (10-6).6
Pediatric ALL vs MFC
This study evaluated MRD in the BM of 579 pediatric B-ALL patients from the (COG) trials AALL0331 or AALL0232. The threshold for MFC and clonoSEQ was 10-4 (1:10,000). MRD was assessed post-induction.7
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
- Pulsipher MA, et al. Blood Cancer Discov. 2022;3(1):66-81.
- Pulsipher MA, et al. Blood. 2015;125(22):3501-3508.
- Oriol A, et al. Haematologica. 2010;95(4):589-596.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Acute Lymphoblastic Leukemia V.1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed July 1, 2022. 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.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed July 1, 2022. 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.
- Short NJ, et al. Blood Adv. 2022;6(13):4006-4014.
- Wood B, et al. Blood. 2018;131(12):1350-1359.
- Pulsipher M, et al. Poster presented at: the 60th ASH Annual Meeting and Exposition; December 1-4, 2018; San Diego, California.
- Muffly L, et al. Blood Adv. 2021;5(16):3147-3151.
- Sala Torra O, et al. Biol Blood Marrow Transplant. 2017;23(4):691-696.
- Logan AC, et al. Biol Blood Marrow Transplant. 2014;20(9):1307-1313.