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    TEST:
    FoundationOne® Liquid CDx

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    1d
    Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD (clinicaltrials.gov)
    P=N/A, N=340, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting
    Enrollment closed • Liquid biopsy
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    FoundationOne® Liquid CDx
    8d
    Case report: immunotherapy response in pancreatic cancer after MSI-H emerged post-chemotherapy. (PubMed, Front Oncol)
    Given her favorable clinical condition and emerging molecular findings, pembrolizumab was initiated...This case illustrates the potential emergence of MSI-H during the disease course of PDAC and highlights the clinical value of repeat molecular profiling at progression. It also highlights clinically relevant discrepancies in MSI detection between liquid biopsy platforms and supports the role of immunotherapy in selected patients with evolving molecular features.
    Journal • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • MSI-H
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    TP53 (Tumor protein P53) • MSI (Microsatellite instability)
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    TP53 mutation • MSI-H/dMMR
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    Guardant360® CDx • FoundationOne® Liquid CDx
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    Keytruda (pembrolizumab)
    20d
    NEOPRISM-CRC: NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer (clinicaltrials.gov)
    P2, N=88, Recruiting, University College, London | Trial completion date: Dec 2028 --> Jul 2029 | Trial primary completion date: Feb 2026 --> Jul 2026
    Trial completion date • Trial primary completion date • Tumor mutational burden • dMMR
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    MSI (Microsatellite instability)
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    MSI-H/dMMR
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    FoundationOne® CDx • FoundationOne® Liquid CDx
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    Keytruda (pembrolizumab)
    24d
    NCI-2017-02296: Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes (clinicaltrials.gov)
    P2, N=60, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Tumor mutational burden
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    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • ABL1 (ABL proto-oncogene 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • STK11 (Serine/threonine kinase 11) • NPM1 (Nucleophosmin 1) • POLE (DNA Polymerase Epsilon) • CCND1 (Cyclin D1) • BAP1 (BRCA1 Associated Protein 1) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • ATRX (ATRX Chromatin Remodeler) • CHEK2 (Checkpoint kinase 2) • SMARCB1 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily B, Member 1) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • POLD1 (DNA Polymerase Delta 1) • CHEK1 (Checkpoint kinase 1) • BARD1 (BRCA1 Associated RING Domain 1) • FANCL (FA Complementation Group L) • BRD4 (Bromodomain Containing 4) • DOT1L (DOT1 Like Histone Lysine Methyltransferase) • FANCE (FA Complementation Group E) • FANCG (FA Complementation Group G) • IKBKE (Inhibitor Of Nuclear Factor Kappa B Kinase Subunit Epsilon) • FANCC (FA Complementation Group C)
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    PALB2 mutation • BRIP1 mutation
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    FoundationOne® CDx • FoundationOne® Liquid CDx
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    Lynparza (olaparib)
    24d
    Second Line Treatment Decision as Per Standard of Care or Foundation Medicine in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer. (PubMed, Cancer Med)
    Using FMI data, clinicians were able to direct patients toward clinical trials and to modify SOC clinical management for several NSCLC patients. These results demonstrate the benefit of FMI genomic profiling in identifying actionable driver mutations that would otherwise be missed by SOC methodology. The findings suggest that CGP is a promising and robust tool for improving personalized medicine in NSCLC treatment in Spain.
    Journal
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • 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)
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    EGFR mutation • BRAF mutation • HER-2 mutation • ALK mutation
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    1m
    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
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    TP53 (Tumor protein P53) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • NF1 (Neurofibromin 1)
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    IDH wild-type
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    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    2ms
    Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. (clinicaltrials.gov)
    P1/2, N=40, Active, not recruiting, Criterium, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Aug 2024 --> Mar 2026
    Enrollment closed • Trial completion date • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CD4 (CD4 Molecule)
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    HER-2 positive • PIK3CA mutation
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    Guardant360® CDx • FoundationOne® Liquid CDx • therascreen® PIK3CA RGQ PCR Kit
    |
    Piqray (alpelisib) • fulvestrant • Tukysa (tucatinib)
    2ms
    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)
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    HER-2 mutation • ESR1 mutation
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    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx
    |
    everolimus • dexamethasone • Orserdu (elacestrant)
    2ms
    Real-world insights from comprehensive genomic profiling in patients with metastatic castration-resistant prostate cancer. (PubMed, Jpn J Clin Oncol)
    CGP identified BRCA PVs, MSI-high, or TMB-high in 20% of patients with metastatic CRPC, supporting its value in guiding precision oncology. However, only some patients received matched therapy, supporting earlier CGP testing. Routine integration of CGP may facilitate precision oncology-guided treatment decision-making in this population.
    Journal • Real-world evidence • Tumor mutational burden • BRCA Biomarker • MSi-H Biomarker • PD(L)-1 Biomarker
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    TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • BRCA (Breast cancer early onset)
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    TMB-H • MSI-H/dMMR
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    FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    |
    Keytruda (pembrolizumab)
    2ms
    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
    3ms
    Detection of a Rare Intra-ALK Inversion and ALK Rearrangement in a Lung Adenocarcinoma Patient by FoundationOne Liquid CDx and Successful Treatment with Alectinib: Case Report. (PubMed, JTO Clin Res Rep)
    This case highlights the value of next-generation sequencing-based profiling in detecting rare actionable alterations missed by standard tests. We also include a discussion on why the EML4-AKL fusion was not detected in the usual test.
    Journal • IO biomarker
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    ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4)
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    ALK rearrangement
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    FoundationOne® Liquid CDx • Oncomine™ Dx Target Test
    |
    Alecensa (alectinib)
    3ms
    Prognostic significance of tumor fraction in advanced sarcoma: highlighting a novel circulating biomarker. (PubMed, Clin Exp Med)
    Our findings demonstrate that ctDNA TF provides non-invasive, real-time prognostic information in this rare and heterogeneous tumor type, with potential applications for patient stratification, treatment planning, and clinical trial design. Prospective validation is warranted to define standardized TF thresholds and support its integration into sarcoma care.
    Journal
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    STING (stimulator of interferon response cGAMP interactor 1)
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    FoundationOne® Liquid CDx