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our Premium Content: News alerts, weekly reports and conference plannersTEST:FoundationOne® CDx
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Company:
RocheType:
FDA Approved
Related tests:
FoundationOne CDx is the first FDA-approved broad companion diagnostic (CDx) to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor. It is clinically and analytically validated for solid tumors, including: NSCLC, Colorectal, Breast, Ovarian, and Melanoma. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient’s cancer.
Cancer:
Biliary Tract Cancer, Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Melanoma, Metastatic Castration-Resistant Prostate Cancer, Non Small Cell Lung Cancer, Ovarian Cancer, Prostate Cancer, Solid Tumor
Gene:
AKT1 (V-akt murine thymoma viral oncogene homolog 1), ALK (Anaplastic lymphoma kinase), ATM (ATM serine/threonine kinase), BARD1 (BRCA1 Associated RING Domain 1), BRAF (B-raf proto-oncogene), BRCA1 (Breast cancer 1, early onset)
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AKT1 (V-akt murine thymoma viral oncogene homolog 1), ALK (Anaplastic lymphoma kinase), ATM (ATM serine/threonine kinase), BARD1 (BRCA1 Associated RING Domain 1), BRAF (B-raf proto-oncogene), BRCA1 (Breast cancer 1, early onset), BRCA2 (Breast cancer 2, early onset), BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1), CDK12 (Cyclin dependent kinase 12), CHEK1 (Checkpoint kinase 1), CHEK2 (Checkpoint kinase 2), EGFR (Epidermal growth factor receptor), ER (Estrogen receptor), FANCL (FA Complementation Group L), FGFR2 (Fibroblast growth factor receptor 2), HER-2 (Human epidermal growth factor receptor 2), KRAS (KRAS proto-oncogene GTPase), MET (MET proto-oncogene, receptor tyrosine kinase), NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1), NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2), NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3), PALB2 (Partner and localizer of BRCA2), PGR (Progesterone receptor), PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha), PTEN (Phosphatase and tensin homolog), RAD51B (RAD51 Paralog B), RAD51C (RAD51 paralog C), RAD51D (RAD51 paralog D), RAD54L (DNA Repair And Recombination Protein RAD54), RET (Ret Proto-Oncogene), TMB (Tumor Mutational Burden)
Drug:
Akeega (abiraterone/niraparib), Alecensa (alectinib), Alunbrig (brigatinib), Braftovi (encorafenib), Cotellic (cobimetinib), Erbitux (cetuximab), Gilotrif (afatinib), Herceptin (trastuzumab), Kadcyla (ado-trastuzumab emtansine), Keytruda (pembrolizumab), Lynparza (olaparib), Mekinist (trametinib), Mektovi (binimetinib), Pemazyre (pemigatinib), Perjeta (pertuzumab), Piqray (alpelisib), Retevmo (selpercatinib), Rozlytrek (entrectinib), Rubraca (rucaparib), Rybrevant (amivantamab-vmjw), Tabrecta (capmatinib), Tafinlar (dabrafenib), Tagrisso (osimertinib), Talzenna (talazoparib), Truqap (capivasertib), Truseltiq (infigratinib), Vectibix (panitumumab), Vitrakvi (larotrectinib), Vizimpro (dacomitinib), Xalkori (crizotinib), Zelboraf (vemurafenib), Zykadia (ceritinib), erlotinib, gefitinib
Method:
Next-Generation Sequencing (NGS)
Approvals
Date
Cancer
Gene
Biomarker
Drug
Approved by
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Approvals
Date
Cancer
Gene
Drug
By
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