HTG EdgeSeq ALKPlus Assay EU Product Sheet
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HTG EdgeSeq ALKPlus Assay EU Product Overview HTG’s new sequencing-based assay for detecting ALK status plus more. With just one slide, measure ALK plus: ROS1* RET* NTRK1* HER2* cMET* 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, and 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. HTG EdgeSeq ALKPlus Assay EU vs. ALK FISH Same results from HTG EdgeSeq ALKPlus and ALK FISH tests Positive Cases Different results For In Vitro Diagnostic Use. * Data available in RUO mode — ROS1, RET, NTRK1, HER2, cMET. HTG EdgeSeq ALKPlus Assay EU is not for sale in North America. HTG EdgeSeq ALKPlus Assay EU Negative Cases

■Obtain ALK status using an NGS-based test Consolidate molecular testing to a single platform solution Enable additional research on potential therapeutic agents Ordering Information Analyze 8 or 24 samples per run on Illumina MiSeqDx and Illumina MiSeq next-generation sequencing systems . Samples per Run_Product Description_ 8 1 plate, 8 samples per plate 8 4 plates, 8 samples per plate 24 4 plates, 24 samples per plate Sample Requirements FFPE Tissue 6.5 mm2 from a 5 pm section Partner with HTG HTG EdgeSeq System HTG offers automated workflow solutions for molecular profiling that can be...