The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high-throughput, parallel-sequencing technology to detect sequence variations in 23 genes in DNA and RNA isolated from formalin-fixed, paraffin-embedded tumor (FFPE) tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System.
Sequence variations in NSCLC DNA for the following 23 genes have been reported: AKT1, ALK, BRAF, CDK4, DDR2, EGFR, ERBB2, ERBB3, FGFR2, FGFR3, HRAS, KIT, KRAS, MAP2K1, MAP2K2, MET, MTOR, NRAS, PDGFRA, PIK3CA, RAF1, RET, and ROS1. Sequence variation in NSCLC RNA for the ROS1 gene has also been reported.
The Oncomine Dx Target Test is also indicated as a companion diagnostic to identify: • ROS1 fusion–positive NSCLC patients for treatment with XALKORI® (crizotinib) • BRAF V600E–positive NSCLC patients for treatment with Tafinlar+Mekinist® (dabrafenib in combination with trametinib) • EGFR L858R– and Exon 19 deletion–positive NSCLC patients for treatment with IRESSA® (gefitinib)
The Oncomine Dx Target Test is intended for use on the Ion PGM Dx System and is intended for in vitro diagnostic use by trained personnel in a professional laboratory environment.
Key features of the test are: • Integrated bio-informatics—provides a results report at the end of the test • Based on AmpliSeq technology, requires 10 ng per pool (20 ng total) of nucleic acid • Provided as a complete kit for the complete workflow
From sample to answer The Oncomine Dx Target Test is designed for use with the Ion PGM Dx System, including the instrument, reagents, and software. This system facilitates 21CFR Part 11 compliance, allowing for role-based workflows, sample and reagent tracking, and an audit trail.
Configuration The Oncomine Dx Target Test comes with all the reagents necessary to take an FFPE sample from extraction to result. The test includes the following components to provide you with a complete NGS workflow solution: • Ion Torrent FFPE sample extraction kit • Oncomine Dx Target Test panel and controls • Ion PGM Dx Library Kit • Ion OneTouch Dx Template Kit • Ion PGM Dx Sequencing Kit • Ion PGM Dx 318 Chip Kit • Oncomine Dx Target Test user guides and assay definition file
For In Vitro Diagnostic Use.
Approved for shipment at Room Temperature or on Wet or Dry Ice