Lung cancer assay kit

1. Performance: Assay concordance with FISH, 93% agreement was achieved between the two methods.
2. Assay Repeatability: Sixteen total NSCLC tumor samples were run on three consecutive days to determine the reproducibility of the product. An overall agreement of 95.6% was achieved across the three days of testing.
3. Intended Use: This kit is based on an in vitro diagnostic (IVD), NGS-based assay intended to measure and analyze mRNA ALK gene fusion events in formalin-fixed, paraffin-embedded lung tumor specimens from patients previously diagnosed with non-small cell lung cancer.