Description
Quantity: 36 Samples
Unit Size: Each
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)
• EGFR exon 20 insertions positive NSCLC patients for treatment with RYBREVANT™ (amivantamab-vmjw)
• ERBB2/HER2 SNVs and exon 20 insertions positive NSCLC patients for treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki)
• RET fusion–positive NSCLC patients for treatment with GAVRETO™(pralsetinib) and RETEVMO® (selpercatinib)
• IDH1 mutation–positive cholangiocarcinoma patients for treatment with TIBSOVO® (ivosidenib)
• BRAF V600E–positive ATC patients for treatment with TAFINLAR® (dabrafenib)in combination with MEKINIST® (trametinib)
• RET mutation–positive MTC patients for treatment with RETEVMO® (selpercatinib)
• RET fusion–positive TC patients for treatment with RETEVMO® (selpercatinib)
• IDH1 and IDH2–positive AC and OG patients for treatment with VORANIGO® (vorasidenib)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 workflowFrom sample to answerThe 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
