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HTG EdgeSeq ALKPlus Assay EU

The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic (IVD), next-generation sequencing (NGS)-based assay intended to measure and analyze mRNA ALK gene fusion events in formalin-fixed, paraffin-embedded (FFPE) lung tumor specimens from patients previously diagnosed with non-small cell lung cancer (NSCLC).   The HTG EdgeSeq ALKPlus Assay EU utilizes our automated HTG EdgeSeq system coupled with the sensitivity and dynamic range of next-generation sequencing based detection, and can be performed in your lab using the
HTG EdgeSeq system, in our VERI/O Laboratory Services as a service, or at one of the Qualified Service Provider (QSP) sites.

Not for sale in North America.

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Features and Benefits

Determine ALK status from NSCLC tumor tissue - using a single section of a needle core biopsy.

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Sample Requirements

Sample Type HTG EdgeSeq ALKPlus 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

Assay concordance with FISH

The HTG EdgeSeq ALKPlus Assay EU was tested against a cohort of NSCLC samples previously tested by the Vysis ALK Break Apart FISH probe kit.  Overall, 93% agreement was achieved between the two methods.

  HTG EdgeSeq ALKPlus Assay EU 
    
  PositiveNegative
Vysis ALK FISHPositive141
 Negative 225

Assay Repeatability

Sixteen total NSCLC tumor samples (8 ALK rearrangement positive, 8 ALK rearrangement negative) were run on three consecutive days to determine the reproducibility of the HTG EdgeSeq ALKPlus Assay EU. All testing was performed using the recommended 6.25 mm2 of tissue input.  An overall agreement of 95.6% was achieved across the three days of testing.  

Table 1: HTG EdgeSeq ALKPlus Assay EU compared with FISH
Day 1
  HTG EdgeSeq ALKPlus Assay EU  
     
  PositiveNegativeQC
FISHPositive800
 Negative 071
Day 2
  HTG EdgeSeq ALKPlus Assay EU  
     
  PositiveNegativeQC
 FISHPositive800
 Negative 170
Day 3
  HTG EdgeSeq ALKPlus Assay EU  
     
  PositiveNegativeQC
FISHPositive611
 Negative 071
Total
  HTG EdgeSeq ALKPlus Assay EU  
     
  PositiveNegativeQC
 FISHPositive2211
 Negative 1212

Intended Use

The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic assay for laboratory professional use intended to measure and analyze mRNA ALK gene fusion events in formalin-fixed, paraffin-embedded (FFPE) lung tumor specimens from patients previously diagnosed with Non-Small Cell Lung Cancer (NSCLC). The HTG EdgeSeq ALKPlus Assay EU is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib).

The profiled data are assessed by a classification algorithm and the tumor determined to be ALK rearrangement postive or ALK rearrangement negative.

The assay is performed using the HTG EdgeSeq system with detection performed on an Illumina MiSeq next-generation sequencer. Results are reported by the HTG Edge host software.

Ordering Information

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

Illumina MiSeq Sequencer Kit Configurations

CE-006-208 HTG EdgeSeq ALKPlus Assay EU (1 x 8)
CE-006-008 HTG EdgeSeq ALKPlus Assay EU (4 x 8)
CE-006-024 HTG EdgeSeq ALKPlus Assay EU (4 x 24)
CE-006-096 HTG EdgeSeq ALKPlus 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 ALKPlus Assay EU.

Resources

HTG EdgeSeq ALKPlus Assay EU Product Sheet
Download pdf 759KB

Publications

A Research Use Only Content Guide for ALK, ROS1, RET, NTRK1, HER2 and cMET Data Generated from the HTG EdgeSeq ALKPlus Assay EU
Download pdf 277KB

Detection of clinically relevant gene fusions with the HTG EdgeSeq ALKPlus Assay EU
Download pdf 399KB


View All Publications

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For further information on the HTG EdgeSeq ALKPlus Assay EU, please fill out the registration form below. Or call us at (877) 507-3259.

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Page last updated January 22, 2018