HTG’s New Sequencing-based Assay for Detecting ALK Status Plus More
The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic, 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 is indicated as an aid in identifying patients eligible for treatment with XALKORI (crizotinib).
Data are available in research use only (RUO) mode for ROS1, RET, NTRK1, HER2, cMET. This all-in-one test is available for use on the Illumina MiSeqDx and Illumina MiSeq sequencers.
Features and Benefits
- Obtain ALK status using an NGS-based test:
results are available in as little as 36 hours
- Consolidates molecular testing into a single platform solution:
automated on the HTG EdgeSeq system
- Enables additional research on potential therapeutic agents:
data on ROS1, RET, NTRK1, HER2, and cMET biomarkers
Agreement with FISH
HTG EdgeSeq ALKPlus Assay EU Shows a 93% Agreement with the Vysis ALK FISH Test
In a total of 42 cases, HTG EdgeSeq ALKPlus Assay EU tests produced the same results as Vysis ALK FISH 39 times. This illustrates a 93% agreement between the results of these two methods.