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TEST:
Seq-MRD® assay

Type:
CE Marked
Related tests:
Evidence

News

12ms
The Effectiveness of Blinatumomab in Clearing Next-Generation Sequencing Measurable Residual Disease in Pediatric Patients with B-Cell Acute Lymphoblastic Leukemia (ASH 2023)
Advanced MRD detection using NGS and blinatumomab made deeper molecular remission in B-ALL patients achievable. Further large-scale studies are warranted to verify the prognostic value of NGS in detecting lower levels of MRD in ALL patients treated in the current immunotherapy era.
Clinical • IO biomarker • Next-generation sequencing
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KMT2A (Lysine Methyltransferase 2A) • IGH (Immunoglobulin Heavy Locus) • PBX1 (PBX Homeobox 1)
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KMT2A rearrangement • MLL rearrangement
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Seq-MRD® assay
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Blincyto (blinatumomab)
over2years
Genetron Health receives CE Mark for Human B Lymphocyte Minimal Residual Disease Detection Kit Seq-MRD® (Genetron Health Press Release)
"Genetron Holdings Limited...today announced it has received a CE Mark for its proprietary Human B Lymphocyte Minimal Residual Disease Detection Kit (Reversible Termination Sequencing Method), which is also known as Seq-MRD® (Registration Number: DE/CA20/01-IVD-Luxuslebenswelt-190/22)...Based on high-throughput next generation sequencing (NGS) technology, Seq-MRD® assay is intended to test the CDR3 regional sequence of the IgH/K/L gene of the B cell receptor (BCR) in bone marrow samples collected from patients with B lymphpocytic leukemia (B-ALL/CLL) and multiple myeloma (MM) before and after the treatment. By screening out significant and specific clonal rearrangement form in a patient's tumor cells, this approach can detect minimal residual disease and provide a reference for the follow-up treatment of cancer survivors."
European regulatory
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Seq-MRD® assay
over2years
Launch
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Seq-MRD® assay