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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.
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.
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.
1.clonoSEQ slips into a pocket on its target.
| 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 |
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Query 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.
Shares ctDNA MRD positivity (molecular residual disease after curative treatment), Minimal / molecular residual disease (MRD), MRD / molecular residual disease testing and the tag test.
Shares ctDNA MRD positivity (molecular residual disease after curative treatment), Minimal / molecular residual disease (MRD), MRD / molecular residual disease testing and the tag test.
Shares ctDNA MRD positivity (molecular residual disease after curative treatment), Minimal / molecular residual disease (MRD), MRD / molecular residual disease testing and the tag test.
Shares Adaptive Biotechnologies, NGS-based MRD (clonoSEQ and molecular MRD), Minimal / molecular residual disease (MRD), MRD / molecular residual disease testing.
Shares Minimal / molecular residual disease (MRD), MRD / molecular residual disease testing, Acute lymphoblastic leukaemia, Multiple myeloma.
Shares MRD negativity (myeloma, 10⁻⁵ / 10⁻⁶), MRD / molecular residual disease testing, Multiple myeloma.
Shares NGS-based MRD (clonoSEQ and molecular MRD), Minimal / molecular residual disease (MRD), Mantle cell lymphoma, MRD / molecular residual disease testing.
Shares Undetectable MRD (uMRD / MRD-negative), Minimal / molecular residual disease (MRD), Chronic lymphocytic leukaemia, Acute lymphoblastic leukaemia.