Lung Cancer Assay Kit

The HTG EdgeSeq ALKPlus Assay EU is a next-generation sequencing (NGS)-based in vitro diagnostic (IVD) assay that is designed to quantify and analyze mRNA ALK gene fusion events in formalin-fixed, paraffin-embedded (FFPE) lung tumor specimens from patients who have been previously diagnosed with non-small cell lung cancer (NSCLC). The HTG EdgeSeq ALKPlus Assay EU integrates the sensitivity and dynamic range of next-generation sequencing-based detection with our automated HTG EdgeSeq system. It can be conducted in your laboratory or at one of the Qualified Service Provider (QSP) sites.Performance

Concordance between the assay and FISH

The HTG EdgeSeq ALKPlus Assay EU was evaluated against a cohort of NSCLC samples that had been previously tested using the Vysis ALK Break Apart FISH probe kit. In total, the two methodologies achieved a 93% agreement.input:
output:Repeatability of the Assay

The HTG EdgeSeq ALKPlus Assay EU was tested on sixteen NSCLC tumor samples, eight of which were positive for ALK rearrangement and eight of which were negative, over the course of three consecutive days. The objective was to ascertain the assay's reproducibility. The recommended 6.25 mm2 of tissue input was employed for all testing. An overall agreement of 95.6% was achieved during the three-day testing period. Intentional ApplicationThe HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic assay designed for laboratory professional use. It is designed to measure and analyze mRNA ALK gene fusion events in formalin-fixed, paraffin-embedded (FFPE) lung tumor specimens from patients who have been previously diagnosed with Non-Small Cell Lung Cancer (NSCLC). The HTG EdgeSeq ALKPlus Assay EU is recommended for the purpose of determining whether patients are eligible for treatment with XALKORI® (crizotinib).