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About clonoSEQ®

clonoSEQ delivers disease monitoring with depth

Depth of detection

Detect MRD at 10-6*, the deepest level currently available†1-3

Depth of prognosis

MRD status is highly prognostic of outcomes and is clinically valuable in real-world practice3-6

Depth of insights

Changing treatment plans based on clonoSEQ results is viable, emerging data shows3

Powered by cutting-edge technology

clonoSEQ precisely measures MRD at the molecular level by leveraging innovations in NGS

Each B- or T-cell receptor is coded by unique DNA sequences made of 3 segments—Variable, Diversity, and Joining—that serve as DNA “barcodes” that can be used to track malignant cells.1
clonoSEQ identifies and quantifies unique B- and T-cell receptors associated with the malignant clone; these MRD results are a direct measure of the tumor, not a surrogate of disease.7,8

Detailed readouts puts disease burden at your fingertips

The Clonality (ID) Report identifies dominant DNA sequences associated with the tumor and is required for subsequent MRD tracking.1
MRD Tracking Tests identify, quantify, and track these dominant DNA sequences to detect changes in disease burden over time.1

Depth of experience

All 33 NCCN® Member Institutions currently use clonoSEQ in clinical practice9

>22,000 unique patients tested9

Test of choice for >40 biopharma companies in >190 clinical trials9

The disconnection between CR and long-term efficacy suggests that persistent disease remains undetected, and measuring deeper responses is necessary to predict and improve long-term outcomes.
-Dr. Avet-Loiseau10

Depth of applications

clonoSEQ blood testing can complement or replace bone marrow assessment

Concordant

Across lymphoid malignancies, MRD positivity via blood‡ is indicative of positivity in marrow11-15

Convenient

Blood draws are less invasive than bone marrow aspirate

Consistent

Blood testing allows you to stay on top of changes in disease burden through serial MRD monitoring, while potentially exposing patients to fewer bone marrow draws

Emerging data highlight utility of blood testing across lymphoid malignancies

Multiple myeloma

FDA-cleared in bone marrow, CLIA-validated in peripheral blood

If peripheral blood is MRD positive, there is a high likelihood that disease is also present in bone marrow15

CLL

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

Clinical guidelines recommend blood testing, and MRD negativity with clonoSEQ using peripheral blood predicted longer PFS1,16

Adult ALL

FDA-cleared in bone marrow, CLIA-validated in peripheral blood

81% to 89% concordance between peripheral blood and bone marrow results11,13,14

Pediatric ALL

FDA-cleared in bone marrow, CLIA-validated in peripheral blood

clonoSEQ detected disease via peripheral blood‡ that was not detected by MFC via bone marrow12

DLBCL

CLIA-validated in peripheral blood and bone marrow

clonoSEQ can detect residual disease at lower levels that imaging may miss17,18

CR, complete response; ctDNA, circulating tumor DNA; FCR, fludarabine + cyclophosphamide + rituximab; MFC, multiparameter flow cytometry; NGS, next-generation sequencing; PFS, progression-free survival; uMRD, undetectable minimal residual disease.

*Given sufficient sample material.

†For multiple myeloma, CLL, and ALL. For DLBCL, clonoSEQ identifies ctDNA in the blood, detecting residual disease at a sensitivity of a single tumor molecule.

‡Testing for validated sample types other than bone marrow (in B-ALL, multiple myeloma, CLL) and peripheral blood (in CLL) is available via Adaptive’s CLIA-validated LDT service. Other sample types have not been cleared or approved by the FDA.

About the studies

MM: A review article, which discussed various methods for detecting MRD via blood in multiple myeloma, found concordance between results in bone marrow and peripheral blood.15

CLL: Data derived from a phase 2 study of 111 CLL patients receiving FCR as frontline therapy. Of 111 patients, 75 provided bone marrow and 62 provided peripheral blood. Twenty-six patients provided both peripheral blood and bone marrow. uMRD was defined as <10-6.1

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.12

Adult ALL: Three studies assessed 126, 54, and 37 paired bone marrow and peripheral blood samples from 62, 32, and 29 patients with adult ALL.11,13,14

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

  • clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020.
  • Short NJ, et al. Am J Hematol. 2019;94(2):257-265.
  • Martinez-Lopez J, et al. J Hematol Oncol. 2021;14(1):126.
  • Thompson PA, et al. Leukemia. 2018;32(11):23‌88-23‌98.
  • Friend BD, et al. Pediatr Blood Cancer. 2020;67(2):e28079.
  • Al-Sawaf O, et al. J Clin Oncol. 2021;39(36):40‌49-40‌60.
  • Carlson CS, et al. Nat Commun. 2013;4:2680.
  • Faham M, et al. Blood. 2012;120(26):51‌73-51‌80.
  • Data on file. Adaptive Biotechnologies. 2021.
  • Avet-Loiseau H, et al. Blood. 2015;126(23):191.
  • Logan AC, et al. Biol Blood Marrow Transplant. 2014;20(9):1307-1313.
  • 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.
  • O’Brien A, et al. Clin Lymphoma Myeloma Leuk. 2022;22(1):e34-e40.
  • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.3.2022. © 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.
  • Roschewski M, et al. Lancet Oncol. 2015;16(5):541-549.
  • Frank MJ, et al. J Clin Oncol. 2021;39(27):30‌34-30‌43.