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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 lab using the HTG EdgeSeq system or at one of the Qualified Service Provider (QSP) sites. The HTG EdgeSeq ALKPlus Assay EU is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib).