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    TEST:
    FoundationOne® CDx

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    9d
    Molecular Profiling across 80,000 Patients with Lung Cancer. (PubMed, J Thorac Oncol)
    This is the largest NSCLC dataset analyzed for biomarker distribution across histologies, age, sex and genetic ancestry. This dataset confirms sufficient enough biomarker prevalence across many histological subtypes of NSCLC, providing reassurance that all NSCLC cases should be considered for biomarker workup.
    Journal • Tumor mutational burden
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    KRAS G12C • HER-2 amplification • MET amplification • ALK rearrangement • TMB-L • ROS1 rearrangement • RET rearrangement • KRAS G12
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    FoundationOne® CDx
    12d
    Gemcitabine/nab-paclitaxel plus S-1 combination compared with gemcitabine/nab-paclitaxel in advanced pancreatic ductal adenocarcinoma: a retrospective study. (PubMed, Ther Adv Med Oncol)
    No treatment-related mortality was found. The S-1 could be combined with GA as another potential triplet combination treatment option for advanced PDAC.
    Retrospective data • Journal
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    FoundationOne® CDx
    |
    gemcitabine • albumin-bound paclitaxel • Teysuno (gimeracil/oteracil/tegafur)
    13d
    Limited reliability of H3K27M detection using a commercially available blood-based comprehensive genomic profiling test in patients with diffuse midline gliomas: analysis of the nationwide C-CAT database in Japan. (PubMed, Int J Clin Oncol)
    Our findings indicate a critical limitation of F1 Liquid in detecting the H3K27M and other significant mutations in diffuse midline glioma.
    Journal
    |
    TP53 (Tumor protein P53) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • NF1 (Neurofibromin 1)
    |
    IDH wild-type
    |
    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    14d
    LUNG-MAP Sub-Study: Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial) (clinicaltrials.gov)
    P2, N=124, Active, not recruiting, SWOG Cancer Research Network | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    BRAF V600E • KRAS mutation • EGFR mutation • BRAF V600 • EGFR T790M • RET fusion • MET exon 14 mutation • ALK fusion • ROS1 fusion • MET mutation • RET positive
    |
    FoundationOne® CDx
    |
    Retevmo (selpercatinib)
    25d
    ADELA: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (clinicaltrials.gov)
    P3, N=240, Recruiting, MedSIR | Active, not recruiting --> Recruiting
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation • ESR1 mutation
    |
    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx
    |
    everolimus • dexamethasone • Orserdu (elacestrant)
    26d
    A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation. (clinicaltrials.gov)
    P1, N=14, Recruiting, PMV Pharmaceuticals, Inc | Not yet recruiting --> Recruiting
    Enrollment open
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 Y220C
    |
    FoundationOne® CDx • MSK-IMPACT • MSK-ACCESS
    |
    metformin • rezatapopt (PC14586) • midazolam hydrochloride
    26d
    Molecular Profiling and Matched Targeted Therapy for Patients With Advanced Melanoma: Results From Part 1 of the MatchMEL Study. (PubMed, JCO Precis Oncol)
    Our findings suggest significant clinical, pathologic, and molecular correlations in an Australian cohort of advanced melanoma treated with ICIs. Patients with NF1 mutation exhibited higher TMB, which was associated with improved response to ICIs.
    Journal • Tumor mutational burden • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • NRAS (Neuroblastoma RAS viral oncogene homolog) • NF1 (Neurofibromin 1)
    |
    TMB-H • BRAF mutation • NRAS mutation • BRAF V600 • BRAF wild-type • RAS wild-type • NRAS wild-type
    |
    FoundationOne® CDx
    1m
    Potential Utility of Comprehensive Genomic Profiling to Predict Venous Thromboembolism in Patients with Solid Cancer. (PubMed, J Thromb Haemost)
    The current exploratory study identified several genomic variants potentially associated with a high risk of cancer-associated VTE, which may indicate potential clinical utility of comprehensive genomic profiling for accurate prediction of VTE events in cancer patients.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • NOTCH1 (Notch 1)
    |
    FoundationOne® CDx
    1m
    NCI 10211: Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2026 --> Jan 2027
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • MSI (Microsatellite instability)
    |
    HER-2 positive • TP53 mutation • MSI-H/dMMR
    |
    FoundationOne® CDx
    |
    irinotecan • berzosertib (M6620)
    1m
    A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden (clinicaltrials.gov)
    P2, N=37, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> Dec 2026 | Trial primary completion date: May 2026 --> Dec 2026
    Trial completion date • Trial primary completion date • Checkpoint inhibition • Tumor mutational burden • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • TERT (Telomerase Reverse Transcriptase) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • ATRX (ATRX Chromatin Remodeler)
    |
    TP53 mutation • EGFR mutation • EGFR amplification • CDKN2A deletion • IDH wild-type
    |
    FoundationOne® CDx
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar)
    1m
    ASPiRATION-2 Liquid: An observational cohort study to assess the impact of longitudinal molecular profiling using circulating tumour DNA (ctDNA) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) after failure of genomically targeted therapy. (ACTRN12626000225314)
    P=N/A, N=500, Not yet recruiting, The University of Sydney
    New trial • Circulating tumor DNA
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NRG1 (Neuregulin 1) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    EGFR mutation • BRAF mutation • MET exon 14 mutation • RET mutation • ROS1 fusion • NRG1 fusion
    |
    FoundationOne® CDx • TruSight Oncology 500 Assay
    1m
    Assessing the Impact of Comprehensive Genomic Profiling on Therapeutic Selection for Advanced Solid Tumors in Portugal. (PubMed, Curr Oncol)
    The FRONTAL study highlighted the clinical relevance of CGP in advanced solid tumors. Over half of the patients had actionable alterations, a quarter had therapy changes based on CGP results, and improved disease outcome was observed in approximately 15% of the cohort.
    Journal
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    FoundationOne® CDx • FoundationOne® Liquid CDx • FoundationOne® Heme CDx