Lung cancer assay kit

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 or at one of the Qualified Service Provider (QSP) sites. 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. 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. 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).