# clonoSEQ

Source: https://onco.cc/drugs/clonoseq/  
OnCo record `clonoseq` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A DNA test that counts leftover leukaemia, myeloma or lymphoma cells down to one in a million, used to decide whether treatment has really worked.

## Summary

Adaptive Biotechnologies' clonoSEQ was granted FDA De Novo authorisation on 28 September 2018 (DEN170080) for minimal residual disease assessment in bone marrow from patients with acute lymphoblastic leukaemia and multiple myeloma, with chronic lymphocytic leukaemia added in 2020 and blood-based testing for some indications since. It is the reference MRD method in myeloma trials (the International Myeloma Working Group threshold of 10^-5 and 10^-6) and is covered by Medicare. MRD negativity by clonoSEQ has been accepted by the FDA as an endpoint supporting accelerated approval in myeloma (2024 advisory committee), which ties the test directly to how new drugs are approved.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: test
- Brand: clonoSEQ
- Modality: NGS minimal residual disease test (immunoglobulin and T-cell receptor clonotypes)
- Mechanism: Multiplex PCR and sequencing of rearranged IGH, IGK, IGL, TRB and TRG loci identify the dominant malignant clonotypes at diagnosis, then track them in bone marrow or blood to a sensitivity of one cell in a million.
- Approvals: US 2018: MRD in bone marrow, B-cell acute lymphoblastic leukaemia and multiple myeloma (De Novo); US 2020: MRD in chronic lymphocytic leukaemia

## Notes

- What a result means: 'MRD negative' means no cancer cells were detected at the assay's sensitivity, which predicts longer remission; 'MRD positive' may prompt continued or changed therapy depending on the disease.

## Sources

- FDA De Novo DEN170080: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170080
- clonoSEQ: https://www.clonoseq.com

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/), [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [Mantle cell lymphoma](https://onco.cc/cancers/mantle-cell-lymphoma/), [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/)
- technologies: [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/), [NGS-based MRD (clonoSEQ and molecular MRD)](https://onco.cc/technologies/ngs-mrd-clonoseq/)
- companies: [Adaptive Biotechnologies](https://onco.cc/companies/adaptive-biotechnologies/)
- terms: [Minimal / molecular residual disease (MRD)](https://onco.cc/terms/mrd/), [MRD negativity (myeloma, 10⁻⁵ / 10⁻⁶)](https://onco.cc/terms/mrd-negativity-myeloma/), [MRD-negative complete remission](https://onco.cc/terms/mrd-negative-cr/), [Undetectable MRD (uMRD / MRD-negative)](https://onco.cc/terms/umrd/)
- trials: [A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP](https://onco.cc/trials/nct06828991/), [Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma](https://onco.cc/trials/nct06252675/), [Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance](https://onco.cc/trials/nct06483100/)
- biomarkers: [ctDNA MRD positivity (molecular residual disease after curative treatment)](https://onco.cc/biomarkers/ctdna-mrd-positive/)

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