|Sample Type||HTG EdgeSeq DLBCL Cell of Origin Assay EU|
Larger sample input amounts must be diluted. Please consult the assay package insert and HTG EdgeSeq System User Manual for more details.
|FFPE Tissue||One 5 µm section|
Day-to-day repeatability was evaluated using 80 DLBCL samples (40 ABC, 40 GCB) previously characterized by Affymetrix microarray analysis.
Approximately 5 mm² of FFPE tissue was tested in each sample well and sequenced on three separate days using a single
HTG EdgeSeq processor and Illumina MiSeq sequencer. Of the 240 sample data sets produced, 236 (98.33%) passed pre-classification QC to ensure data met minimum specifications. Table 1 describes the final results of sample subtyping from the
HTG EdgeSeq DLBCL Cell of Origin Assay EU compared with Affymetrix microarray. The overall agreement rate was 100% over all days.
|Day 1||Day 2||Day 3|
The HTG EdgeSeq DLBCL Cell of Origin Assay EU was compared to immunohistochemistry (IHC) methods using two independent sample cohorts. A cohort of 132 DLBCL samples previously characterized as ABC or GCB using the Visco-Young method and a second cohort of 24 DLBCL samples were characterized using the Choi method both produced agreements in line with reports from the literature.
Fourteen previously characterized clinical DLBCL samples were lysed at two sample input amounts (1.5 mm2 and 5 mm2). Three replicates for all samples were processed on three HTG EdgeSeq processors and were sequenced on a single day. A total of 252 GCB/ABC classification calls were generated, across all conditions.
A total of 97% of samples (244/252) passed the pre-classification QC metrics. Ninety-nine percent (99%) agreement was obtained when unclassified samples were excluded (1 total misclassification); 97% agreement was obtained when unclassified results were included. There was a total of 8 unclassified results, 6 of these obtained from a single sample. These agreement rates are summarized in Table 4.
Table 4: Within Processor and Sample Input Agreement
|% Pass QC||% Agree|
|Instrument 1 (N=83)||98.8||94.0|
|Instrument 2 (N=81)||96.4||97.5|
|Instrument 3 (N=80)||95.2||97.5|
|% Pass QC||% Agree|
|1.5 mm Sample (N=118)||93.7||94.9|
|5 mm Sample (N=126)||100||97.6|
The HTG EdgeSeq DLBCL Cell of Origin Assay EU is an in vitro diagnostic assay that uses gene expression profiling to determine the cell of origin (COO) subtype of diffuse large B-cell lymphoma (DLBCL) tumors from FFPE tissue. The profiled data are assessed by a classification algorithm and the tumor 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 detection performed on an Illumina MiSeq sequencer. Results are reported by the HTG Edge host system.
When placing an order, please specify the catalog number. The HTG EdgeSeq DLBCL Cell of Origin Assay EU is compatible with Illumina MiSeq sequencer.
CE-003-008 HTG EdgeSeq DLBCL Cell of Origin Assay EU (4 X 8)
CE-003-024 HTG EdgeSeq DLBCL Cell of Origin Assay EU (4 X 24)
CE-003-096 HTG EdgeSeq DLBCL Cell of Origin Assay EU (1 X 96)
Learn more about the HTG EdgeSeq DLBCL Cell of Origin Assay EU
Biopharma and HTG Molecular Diagnostics Brochure
Download pdf 678KB
Comprehensive Tumor Profiling Brochure
Download pdf 464KB
HTG EdgeSeq DLBCL Cell of Origin Assay Gene List
Download pdf 341KB
Next-Generation Sequencing for DLBCL Classification
Download pdf 740KB
For further information about the HTG EdgeSeq DLBCL Cell of Origin Assay EU, please fill out the registration form below. Or call us at (877) 507-3259.
Page last updated January 18, 2018