clonoSEQ is now covered by Medicare for MCL patients.
It is the first Medicare-reimbursed MRD test for patients with MCL and is clinically available as a CLIA-validated LDT.
For more information about incorporating clonoSEQ into your clinical practice for MCL patients, click here.

About clonoSEQ

Detect subtle changes and manage patients decisively along the treatment continuum

clonoSEQ can powerfully detect measurable residual disease (MRD) throughout the treatment continuum—enabling you to confidently evaluate changes in disease burden and leap into action.1

clonoSEQ can powerfully detect measurable residual disease (MRD) throughout the treatment continuum—enabling you to confidently evaluate changes in disease burden and leap into action.1

Why monitor MRD?

Today, newer therapies are helping more patients achieve deeper responses and better outcomes.2-4 However, current assessment tools often cannot detect small but significant levels of residual disease, which can be the source of relapse.3-5

Monitoring MRD status over time identifies changes in disease dynamics and provides valuable information for care decisions

clonoSEQ closely measures disease burden

As blood cancer fluctuates, monitoring with clonoSEQ provides enhanced clarity into the status of MRD.

Test at multiple timepoints across your patient’s journey to measure the effectiveness of treatment and inform changes as needed.

Identify patients’ tumor-associated DNA sequences for monitoring

Identifying dominant clonal DNA sequences with the Clonality (ID) Test enables subsequent MRD monitoring to help inform personalized treatment decisions

Predict long-term outcomes6-10

Tracking (MRD) Reports show clonoSEQ MRD levels, which are highly prognostic of outcomes, throughout patient care

Assess response to treatment10-14

Determine whether to stay the course or adjust treatment based on your patient’s response to treatment

Detect potential relapse
earlier15-18

Be confident that the earliest signs of MRD resurgence are detected

Inform changes in treatment10-14,19

MRD status may be helpful to determine whether a patient can stop or change therapy or if they should stay the course

Monitor disease burden over
time5,6,8,10-12,14,16,20-23

See subtle changes in disease burden in patients who are on or off therapy

clonoSEQ can complement other measurement tools with a simple blood-based test that offers a clear view of disease burden13,24-26

How clonoSEQ works


clonoSEQ allows you to precisely measure MRD at the molecular level through proprietary bioinformatics and innovations in next-generation sequencing (NGS).

The test leverages the basic biology of B- and T-cells to identify DNA sequences unique to the malignant cell population.27,28

The test leverages the basic biology of B- and T-cells to identify DNA sequences unique to the malignant cell population.27,28

These clones can then be tracked by their unique DNA signature or “barcode.”1

These clones can then be tracked by their unique DNA signature or “barcode.”1

clonoSEQ quantifies the malignant cell population comprising MRD so clonoSEQ results are a direct measure of cancer sequences, and not a surrogate marker of disease27,28

Clarity throughout your patient’s journey

Detailed reports put MRD status in your hands.

Measuring MRD with clonoSEQ involves a one-time Clonality (ID) Test and then subsequent Tracking (MRD) Tests thereafter.

Learn more about the clonoSEQ reports

Join physicians in
going beyond
standard disease
burden assessment

All 33 NCCN® Member Institutions, hundreds of academic institutions, and
community centers currently use clonoSEQ in clinical practice.29†

>40

biopharma companies
routinely use clonoSEQ29

>190

clinical trials
conducted to date29

>51K

unique patients
tested29

Order clonoSEQ

Learn how clonoSEQ can help your patients across several disease states

Multiple Myeloma

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

DLBCL

CLIA-validated in peripheral blood and bone marrow

CLL

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

Adult ALL

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

Pediatric ALL

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

MCL

CLIA-validated in peripheral blood and bone marrow

MCL, mantle cell lymphoma.

*Testing for validated sample types other than bone marrow (in 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. Peripheral blood is FDA-cleared for CLL and plasma from blood is CLIA-validated/preferred for DLBCL.

†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.

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 measurable 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). To review the FDA-cleared uses of clonoSEQ, visit clonoSEQ.com/technical-summary.

References

  1. clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020.
  2. Molica S, et al. Clin Lymphoma Myeloma Leuk. 2019;19(7):423-430.
  3. Kumar S, et al. Lancet Oncol. 2016;17(8):e328-e346.
  4. Akabane H, et al. Clin Adv Hematol Oncol. 2020;18(7):413-422.
  5. Martinez-Lopez J, et al. Blood. 2014;123(20):3073-3079.
  6. Perrot A, et al. Blood. 2018;132(23):2456-2464.
  7. Kovacs G, et al. J Clin Oncol. 2016;34(31):3758-3765.
  8. Al-Sawaf O, et al. Paper presented at: the 62nd ASH Annual Meeting and Exposition; December 5-8, 2020; virtual. Abstract 127. 
  9. Short N, et al. Blood Adv. 2022;6(13):4006-4014.
  10. Frank M, et al. J Clin Oncol. 2021;39(27):3034-3043.
  11. Costa L, et al. Lancet Haematol. 2023;10(11):e890-e901.
  12. Costa L, et al. Poster presented at: the 64th ASH Annual Meeting and Exposition; December 10-13, 2022; New Orleans, LA. Poster 3227. 
  13. Thompson P, et al. Blood. 2019;134(22):1951-1959. 
  14. Pulsipher M, et al. Blood Cancer Discov. 2022;3(1):66-81.
  15. Cavo M, et al. Blood. 2022;139(6):835-844. 
  16. Soumerai J, et al. Lancet Haematol. 2021;8(12):e879-e890.
  1. Logan A, et al. Biol Blood Marrow Transplant. 2014;20(9):1307-1313.
  2.  Roschewski M, et al. Lancet Oncol. 2015;16(5):541-549. 
  3. Munshi N, et al. Paper presented at: the 64th ASH Annual Meeting and Exposition; December 10-13, 2022; New Orleans, LA. Abstract 2030. 
  4. Merryman R, et al. Blood Adv. 2023;7(17):4748-4759. 
  5. Ananth S, et al. Paper presented at: the 65th ASH Annual Meeting and Exposition; December 9-12, 2023; San Diego, CA. Abstract 1673. 
  6. Kumar A, et al. Paper presented at: the 65th ASH Annual Meeting and Exposition; December 9-12, 2023; San Diego, CA. Abstract 738.
  7. Rezazadeh A, et al. Clin Lymphoma Myeloma Leuk. 2023. 10:S2152-2650(23)02195-X [online ahead of print]. doi: 10.1016/j.clml.2023.12.006
  8. Vij R, et al. Clin Lymphoma Myeloma Leuk. 2014;14(2):131-139.e1.
  9. Muffly L, et al. Blood Adv. 2021;5(16):3147-3151. 
  10. Muffly L, et al. Paper presented at: the 62nd ASH Annual Meeting and Exposition; December 5-8, 2020; virtual. Abstract 975.
  11. Carlson C, et al. Nat Commun. 2013;4:2680. 
  12. Faham M, et al. Blood. 2012;120(26):5173-5180. 
  13. Data on file. Adaptive Biotechnologies. 2023.