Guardant360® CDx is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of cell-free circulating tumor DNA (ctDNA) in blood specimens of advanced solid-tumor cancer patients and evaluates 74 genes. It tests four major classes of alterations relevant for treatment selection: point mutations, indels (insertions/deletions), copy number amplifications, and fusions/rearrangements. The test is intended to be used as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients who may benefit from treatment with Tagrisso® (osimertinib).

Cancer:

Colorectal Cancer, Gastric Cancer, Non Small Cell Lung Cancer, Pancreatic Cancer

Gene:

AKT1 (V-akt murine thymoma viral oncogene homolog 1), ALK (Anaplastic lymphoma kinase), APC (APC Regulator Of WNT Signaling Pathway), AR (Androgen receptor), ARAF (A-Raf Proto-Oncogene), ARID1A (AT-rich interaction domain 1A), ATM (ATM serine/threonine kinase), BCL11B (BAF Chromatin Remodeling Complex Subunit BCL11B), BRAF (B-raf proto-oncogene), BRCA1 (Breast cancer 1, early onset), BRCA2 (Breast cancer 2, early onset), CCND1 (Cyclin D1), CCND2 (Cyclin D2), CCNE1 (Cyclin E1), CDH1 (Cadherin 1), CDK4 (Cyclin-dependent kinase 4), CDK6 (Cyclin-dependent kinase 6), CDKN2A (Cyclin Dependent Kinase Inhibitor 2A), CTNNB1 (Catenin (cadherin-associated protein), beta 1), DDR2 (Discoidin domain receptor 2), EGFR (Epidermal growth factor receptor), ER (Estrogen receptor), EZH2 (Enhancer of zeste 2 polycomb repressive complex 2 subunit), FBXW7 (F-Box And WD Repeat Domain Containing 7), FGFR1 (Fibroblast growth factor receptor 1), FGFR2 (Fibroblast growth factor receptor 2), FGFR3 (Fibroblast growth factor receptor 3), GATA3 (GATA binding protein 3), GNA11 (G Protein Subunit Alpha 11), GNAQ (G Protein Subunit Alpha Q), GNAS (GNAS Complex Locus), HER-2 (Human epidermal growth factor receptor 2), HNF1A (HNF1 Homeobox A), HRAS (Harvey rat sarcoma viral oncogene homolog), IDH1 (Isocitrate dehydrogenase (NADP(+)) 1), IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2), JAK2 (Janus kinase 2), JAK3 (Janus Kinase 3), KIT (KIT proto-oncogene, receptor tyrosine kinase), KRAS (KRAS proto-oncogene GTPase), MAP2K1 (Mitogen-activated protein kinase kinase 1), MAP2K2 (Mitogen-activated protein kinase kinase 2), MAPK1 (Mitogen-activated protein kinase 1), MAPK3 (Mitogen-Activated Protein Kinase 3), MET (MET proto-oncogene, receptor tyrosine kinase), MLH1 (MutL homolog 1), MPL (MPL Proto-Oncogene, Thrombopoietin Receptor), MYC (V-myc avian myelocytomatosis viral oncogene homolog), NF1 (Neurofibromin 1), NFE2L2 (Nuclear Factor, Erythroid 2 Like 2), NOTCH1 (Notch 1), NPM1 (Nucleophosmin 1), NRAS (Neuroblastoma RAS viral oncogene homolog), NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1), NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3), PDGFRA (Platelet Derived Growth Factor Receptor Alpha), PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha), PTEN (Phosphatase and tensin homolog), PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11), RAF1 (Raf-1 Proto-Oncogene Serine/Threonine Kinase), RB1 (RB Transcriptional Corepressor 1), RET (Ret Proto-Oncogene), RHEB (Ras Homolog, MTORC1 Binding), RHOA (Ras homolog family member A), ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS), SMAD4 (SMAD family member 4), SMO (Smoothened Frizzled Class Receptor), STK11 (Serine/threonine kinase 11), TERT (Telomerase Reverse Transcriptase), TP53 (Tumor protein P53), TSC1 (TSC complex subunit 1), VHL (von Hippel-Lindau tumor suppressor), mTOR (Mechanistic target of rapamycin kinase)

Drug:

Enhertu (fam-trastuzumab deruxtecan-nxki), Lumakras (sotorasib), Orserdu (elacestrant), Rybrevant (amivantamab-vmjw), Tagrisso (osimertinib)

Method:

Next-Generation Sequencing (NGS) / Circulating Tumor DNA (ctDNA)

Approvals

Date

Cancer

Gene

Biomarker

Drug

Approved by

08/07/2020