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HTG EdgeSeq DLBCL Cell of Origin Assay EU

HTG EdgeSeq DLBCL Cell of Origin Assay EU

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.

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Features and Benefits

Determine DLBCL cell of origin classification with as little as
1.5 mm2 of DLBCL tumor tissue - the amount typically seen from a single section of a needle core biopsy.

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Sample Requirements

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 TissueOne 5 µm section

Performance

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.

Table 1: HTG EdgeSeq DLBCL Cell of Origin Assay EU Compared to Affymetrix Microarray
 Day 1Day 2Day 3
    
ABC393840
GCB394040

Assay Agreement to IHC

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.

 
Table 2: HTG EdgeSeq DLBCL Cell of Origin Assay EU Classification Agreement with the Choi IHC Algorithm
 ABCGCBUNC
    
ABC1111
GCB1100
Overall Agreement to Choi IHC 91%
 
Table 3: HTG EdgeSeq DLBCL Cell of Origin Assay EU Classification Agreement with the Visco-Young IHC Algorithm
 ABCGCBUNC 
    
ABC60126
GCB9405
Overall Agreement to Visco-Young IHC 83%

Diagnostic Reproducibility

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)98.894.0
Instrument 2 (N=81)96.497.5
Instrument 3 (N=80)95.297.5
 %  Pass QC% Agree
   
1.5 mm Sample (N=118)93.794.9
5 mm Sample (N=126)10097.6

Intended Use

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.

Ordering Information

When placing an order, please specify the catalog number. The HTG EdgeSeq DLBCL Cell of Origin Assay EU is compatible with Illumina MiSeq sequencer.

Kit Configurations for use with the 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)

For In Vitro Diagnostic Use. Not for sale in North America.

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Resources and Publications

Learn more about the HTG EdgeSeq DLBCL Cell of Origin Assay EU

Resources

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

Publications

Next-Generation Sequencing for DLBCL Classification
Download pdf 740KB


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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.

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Page last updated January 18, 2018