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The HTG EdgeSeq DLBCL Cell of Origin Assay EU is an in vitro diagnostic assay that uses gene expression profiling (GEP) to determine the cell of origin (COO) subtype of diffuse large B-cell lymphoma (DLBCL) tumors from formalin-fixed, paraffin-embedded (FFPE) tissue section. The gene expression data are assessed by a classification algorithm and the tumor samples determined to be of the activated B-cell like (ABC), germinal B-cell like (GCB), or unclassified subtype. The assay is performed using the HTG EdgeSeq system with sequencing performed on an Illumina MiSeq sequencer. Cell of origin results are reported by the HTG Edge host system.
Cancer:
Diffuse Large B Cell Lymphoma
Gene:
AKT1 (V-akt murine thymoma viral oncogene homolog 1), BCL2 (B-cell CLL/lymphoma 2), CD19 (CD19 Molecule), CD276 (CD276 Molecule), CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4), DDX5 (DEAD-Box Helicase 5)
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Drug:
Imbruvica (ibrutinib)
Method:
Next-Generation Sequencing (NGS)
Approvals
Date
Cancer
Gene
Drug
By
07/20/16
CE
Confirmatory trial(s)