MRD Biopharma Services

The power of MRD testing in clinical trials

clonoSEQ MRD testing: Enhancing insights in clinical trials data

Due to transformative therapeutic advancements, patients with lymphoid malignancies are now achieving deeper responses and significantly better outcomes. As a result, clinical trials for new therapies using traditional response measures can take 10-15 years to complete, thereby delaying access to innovative and more effective treatments.

Using clonoSEQ to measure and monitor minimal residual disease (MRD) enables the detection of small yet significant levels of disease. The assay can be a crucial tool to inform drug performance, provide an earlier read on efficacy, and offer a clearer understanding of the depth and duration of response to novel therapies.

clonoSEQ MRD testing in lymphoid cancers

Early and precise read on efficacy

Highly sensitive and specific

Quantitative results

ID disease missed by other measures of response

Used by world’s leading drug developers

Early and precise read on efficacy

Highly sensitive and specific

Quantitative results

ID disease missed by other measures of response

Used by world’s leading drug developers

Unmatched MRD expertise and proven utility

Valuable data and insights throughout the drug development process

Experts in MRD-informed clinical trials

Clinical trial design

Post-hoc analysis

Global regulatory strategy

Supported by more than 150 publications

Clinical trial design

Post-hoc analysis

Global regulatory strategy

Supported by more than 150 publications

Deep sensitivity and validated performance

Detects one in one million cancer cells

Standardized MRD results across all global sites

CE-marked under the European Union’s In Vitro Diagnostic Medical Device Regulation

U.S. regulatory approval

Disease state FDA-cleared CLIA-validated and CLEP approved
Acute lymphoblastic leukemia (ALL)
Chronic lymphocytic leukemia (CLL)
Diffuse large B-cell lymphoma (DLBCL)
Follicular lymphoma (FL)
Mantle cell lymphoma (MCL)
Multiple myeloma
Other non-Hodgkin’s lymphomas

Flexible sample types and timepoints*

  • Fresh or frozen specimens

  • Cellular and circulating tumor DNA (ctDNA)

  • Bone marrow, blood, plasma, and tissue

Global clinical trials and regulatory experience

  • More than 40 pharma partners and 160+ active industry-sponsored clinical trials

  • Secondary endpoint in more than 70 active studies, primary endpoint in 10+ active studies

  • Data generated using clonoSEQ has supported regulatory approvals for various therapeutic modalities, including CAR T, bispecific T-cell engagers, monoclonal antibodies, and BCL2 inhibitors

  • Successfully supported Biopharma partners in more than ten Human Genetics Resources Administration of China (HGRAC) applications

Widely adopted in-clinic

  • In NCCN guidelines and used in clinical practice by all 33 NCCN cancer centers

  • Ordered by 4,100 providers for more than 60,000 patients

  • Broad U.S. payer coverage: over 300 million covered lives (MM and ALL); nearly 200 million covered lives (CLL); over 65 million covered lives (DLBCL and MCL)

How it works

clonoSEQ is a tumor-informed assay

Step 1: ID test

  • Conducted once using a high tumor burden sample
  • Identifies trackable immune receptor DNA sequences associated with a lymphoid malignancy

Step 2: MRD tests

  • Conducted at any timepoint
  • Detects and quantifies the sequence(s) identified in step 1 during or after treatment
  • Even at very low levels, immune receptor DNA sequences associated with a lymphoid malignancy can be detected

Select Publications

CLL

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Identify disease missed by others: clonoSEQ picked up disease missed by flow cytometry, with markedly different outcomes for patients with detectable versus undetectable disease.

Siddiqi T, Maloney DG, Kengerian SS, et al.
Lancet. 2023
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Quantify durability of response: Serial clonoSEQ assessments can be used to assess disease during and after fixed-duration treatment.

Thompson PA, Srivastava J, Peterson C, et al.
Blood. 2019
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Use in accelerated approval: clonoSEQ was employed to characterize efficacy of the first CART product approved for use in CLL.

Al-Sawaf O, Zhang C, Lu T, et al.
J Clin Oncol. 2021
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Define efficacy of novel combinations: Treatment with ibrutinib + venetoclax resulted in deeper responses in elderly or unfit patients as assessed by the clonoSEQ array.

Munir T, Moreno C, Owen C, et al.
J Clin Oncol. 2023
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Characterize risk of recurrence: clonoSEQ identified a cohort of patients with early recurrent disease after discontinuation of treatment by finding slower kinetics of disease clearance in blood.

Soumerai JD, Mato AR, Dogan A, et al.
Lancet Heamatology. 2021

DLBCL

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Noninvasive monitoring: Tumor-related clonotypes were present at much higher levels in the plasma as circulating tumor DNA (ctDNA), compared with the corresponding cellular sample.

Kurtz DM, Green MR, Bratman SV, et al.
Blood. 2015
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Assess response to frontline treatment: Interim ctDNA levels were predictive of time to progression, and regular monitoring during surveillance enabled detection of disease approximately 3.5 months earlier than imaging.

Roschewski M, Staudt LM, Wilson WH.
Blood. 2016
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Predict relapse more effectively than imaging: When patients receiving autologous stem cell transplants were assessed based on both pre-transplant PET and MRD status, MRD was the key driver of outcomes.

Merryman RW, Redd RA, Taranto E, et al.
Blood Adv. 2023
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Differentiate responders and non-responders: In highly refractory patients being treated with a bispecific T-cell engager, MRD negativity correlated with improved progression-free survival, and 100% of patients testing MRD positive at any time relapsed or were censored within 15 months of starting therapy.

Thieblemont C, Phillips T, Ghesquieres H, et al.
EHA 2022 Hybrid Congress.
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Quickly characterize efficacy of CAR T therapies: ctDNA was undetectable in 70% of patients with durable responses to axi-cel at one week post-infusion, and in 100% of these patients by day 90 and thereafter.

Frank MJ, Hossain NM, Bukhari A, et al.
J Clin Oncol. 2021

How can Adaptive help support your clinical development strategy?

Contact Us

Current clients, contact the Alliance Management team at alliancemanagers@adaptivebiotech.com.

* For accepted sample types for each disease state, see the Specimen Guidelines for GCLP Batch Workflow Analysis.

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). clonoSEQ is also 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.