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our Premium Content: News alerts, weekly reports and conference plannersTEST:FoundationOne® Liquid CDx
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Company:
RocheType:
FDA Approved
Related tests:
FoundationOne® Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to detect and report substitutions, insertions and deletions (indels) in 311 genes, including rearrangements and copy number losses only in BRCA1 and BRCA2. FoundationOne® Liquid CDx utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of cancer patients collected in FoundationOne® Liquid CDx cfDNA blood collection tubes included in the FoundationOne® Liquid CDx Blood Sample Collection Kit. FoundationOne Liquid CDx is Intended to be used as a companion diagnostic for: EGFR Exon 19 deletions and EGFR Exon 21 L858R substitution in NSCLC with therapy TRESSA® (gefitinib), TAGRISSO® (osimertinib), TARCEVA® (erlotinib) and for BRCA1, BRCA2 alterations in mCRPC with therapy RUBRACA® (rucaparib).
Cancer:
Breast Cancer, Colorectal Cancer, Metastatic Castration-Resistant Prostate Cancer, Non Small Cell Lung Cancer, Ovarian Cancer, Prostate Cancer
Gene:
ALK (Anaplastic lymphoma kinase), APC (APC Regulator Of WNT Signaling Pathway), AR (Androgen receptor), ARAF (A-Raf Proto-Oncogene), ATM (ATM serine/threonine kinase), BRAF (B-raf proto-oncogene)
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ALK (Anaplastic lymphoma kinase), APC (APC Regulator Of WNT Signaling Pathway), AR (Androgen receptor), ARAF (A-Raf Proto-Oncogene), ATM (ATM serine/threonine kinase), BRAF (B-raf proto-oncogene), BRCA (Breast cancer early onset), BRCA1 (Breast cancer 1, early onset), BRCA2 (Breast cancer 2, early onset), CCND1 (Cyclin D1), CDH1 (Cadherin 1), CDK12 (Cyclin dependent kinase 12), CDK4 (Cyclin-dependent kinase 4), CDK6 (Cyclin-dependent kinase 6), CDKN2A (Cyclin Dependent Kinase Inhibitor 2A), CHEK2 (Checkpoint kinase 2), EGFR (Epidermal growth factor receptor), FGFR1 (Fibroblast growth factor receptor 1), FGFR2 (Fibroblast growth factor receptor 2), FGFR3 (Fibroblast growth factor receptor 3), HER-2 (Human epidermal growth factor receptor 2), KRAS (KRAS proto-oncogene GTPase), MDM2 (E3 ubiquitin protein ligase), MET (MET proto-oncogene, receptor tyrosine kinase), MYC (V-myc avian myelocytomatosis viral oncogene homolog), MYCN (MYCN Proto-Oncogene BHLH Transcription Factor), NF1 (Neurofibromin 1), NTRK (Neurotrophic receptor tyrosine kinase), PALB2 (Partner and localizer of BRCA2), PD-L1 (Programmed death ligand 1), PDCD1LG2 (Programmed Death Ligand 2), 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), RB1 (RB Transcriptional Corepressor 1), ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS), SMO (Smoothened Frizzled Class Receptor), STK11 (Serine/threonine kinase 11), TP53 (Tumor protein P53), VEGFA (Vascular endothelial growth factor A)
Drug:
Akeega (abiraterone/niraparib), Alecensa (alectinib), Alunbrig (brigatinib), Braftovi (encorafenib), Erbitux (cetuximab), Exkivity (mobocertinib), Itovebi (inavolisib), Lynparza (olaparib), Mektovi (binimetinib), Piqray (alpelisib), Rozlytrek (entrectinib), Rubraca (rucaparib), Tabrecta (capmatinib), Tagrisso (osimertinib), erlotinib, gefitinib
Method:
Next-Generation Sequencing (NGS)
Approvals
Date
Cancer
Gene
Biomarker
Drug
Approved by
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Confirmatory trial(s)
Approvals
Date
Cancer
Gene
Drug
By
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Confirmatory trial(s)
