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TEST:
Oncomine™ Dx Target Test

Type:
FDA Approved
Related tests:
The Oncomine Dx Target Test is a next-gen sequencing assay designed to detect variants in 23 genes associated with non-small cell lung cancer (NSCLC). Abnormalities targeted are ROS1 gene fusions and 367 sequence variant "hotspot" mutations in the following genes: AKT1, ALK, BRAF, CDK4, DDR2, EGFR, ERBB2, ERBB3, FGFR2, FGFR3, HRAS, KIT, KRAS, MAP2K1 (aka MEK1), MAP2K2 (aka MEK2), MET, MTOR, NRAS, PDGFRA, PIK3CA, RAF1, RET, and ROS1. This test is indicated as an aid for selecting NSCLC patients for three targeted therapies: Tafinlar® in combination with Mekinist® (dabrafenib/trametinib) in the presence of BRAF V600E mutation, Xalkori® (crizotinib) with ROS1 fusions; and Iressa® (gefitinib) with EGFR L858R mutation or exon 19 deletions.
Cancer:
Non Small Cell Lung Cancer, Thyroid Gland Medullary Carcinoma
Gene:
AKT1 (V-akt murine thymoma viral oncogene homolog 1), ALK1 (Activin A Receptor Like Type 1), BRAF (B-raf proto-oncogene), CDK4 (Cyclin-dependent kinase 4), DDR2 (Discoidin domain receptor 2), EGFR (Epidermal growth factor receptor)
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Drug:
Enhertu (fam-trastuzumab deruxtecan-nxki), Gavreto (pralsetinib), Mekinist (trametinib), Retevmo (selpercatinib), Tafinlar (dabrafenib), Xalkori (crizotinib), gefitinib
Method:
Next-Generation Sequencing (NGS)
Confirmatory trial(s)