clonoSEQ
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.
Overview
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.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2018 | MRD in bone marrow, B-cell acute lymphoblastic leukaemia and multiple myeloma (De Novo) |
| US | 2020 | MRD in chronic lymphocytic leukaemia |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- 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.
Latest papers
topQuery for this drug: (TITLE:"clonoSEQ" OR ABSTRACT:"clonoSEQ") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about clonoSEQ, not a curated reading list.
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