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    TEST:
    FoundationOne® Liquid CDx

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    6d
    Observed RET-Positive Findings Across Routine Comprehensive Genomic Profiling Platforms in Japan: A Nationwide Descriptive Benchmark. (PubMed, Cancers (Basel))
    This nationwide analysis benchmarks how RET-positive findings are surfaced to clinicians across heterogeneous routine CGP implementations in Japan. The data support platform-aware interpretation of RET results in practice, but should not be construed as biologic prevalence estimates or comparative assay performance.
    Journal
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    RET (Ret Proto-Oncogene)
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    RET fusion • RET positive
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    16d
    Clinical Utility of Comprehensive Genomic Profiling for Advanced Non-Small Cell Lung Cancer: A Single-Center Retrospective Study. (PubMed, Thorac Cancer)
    CGP testing can identify actionable mutations missed by conventional diagnostics and may provide additional therapeutic opportunities in NSCLC.
    Retrospective data • Journal
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    EGFR (Epidermal growth factor receptor)
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    EGFR mutation
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    FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    18d
    US FDA Approves FoundationOneCDx and FoundationOne Liquid CDx as Companion Diagnostics for TALZENNA (talazoparib) in Combination with XTANDI (enzalutamide) to Identify Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer (Businesswire)
    "Foundation Medicine...today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx and FoundationOne®Liquid CDx to be used as companion diagnostics for TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide) to identify patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). TALZENNA is first and only PARP inhibitor approved for use with an existing standard of care (XTANDI) for adult patients with both BRCA mutated and non-BRCA HRR gene-mutated mCRPC."
    FDA approval
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    FoundationOne® CDx • FoundationOne® Liquid CDx
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    Talzenna (talazoparib)
    26d
    Liquid Biopsy in Modern Oncology: Advances, Challenges, and Future Perspectives in Early Cancer Detection, Minimal Residual Disease, and Dynamic Patient Monitoring. (PubMed, Curr Oncol Rep)
    Liquid biopsy represents a paradigm shift in precision oncology by enabling real-time, longitudinal tumor profiling. Although significant barriers remain, such as cost, accessibility, and lack of standardization, technological innovations and large-scale validation studies are paving the way for its routine clinical integration.
    Review • Journal • Liquid biopsy • Minimal residual disease
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    Guardant360® CDx • FoundationOne® Liquid CDx • Epi proColon®
    1m
    Clinical Liquid Biopsy Testing for Detection of Actionable Genomic Alterations in Children and Young Adults With Advanced Solid Tumors on the GAIN Study. (PubMed, JCO Precis Oncol)
    ctDNA is prevalent across a wide range of advanced pediatric solid tumors, identifies clinically important variants, changes with radiographic disease burden, and has a clinical impact.
    Journal • Liquid biopsy
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    FoundationOne® Liquid CDx
    1m
    Genomics of MTAP Loss in >500,000 Solid Tumor Specimens Profiled Using Comprehensive Genomic Profiling Platforms. (PubMed, JCO Precis Oncol)
    MTAPloss is a frequent pan-tumor alteration that predicts potential sensitivity to PRMT5 or MAT2A inhibitors. Although most tumors exhibit complete MTAPloss, 16.5% are characterized by partial MTAPloss where clinical benefit remains uncertain. The genomic coalteration landscape reported here may inform future PRMT5 or MAT2A clinical trials, potentially in combination with other agents.
    Journal
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PTEN (Phosphatase and tensin homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • RB1 (RB Transcriptional Corepressor 1) • CCNE1 (Cyclin E1) • MTAP (Methylthioadenosine Phosphorylase) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • SPOP (Speckle Type BTB/POZ Protein) • MAT2A (Methionine Adenosyltransferase 2A)
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    1m
    Detection of Homologous Recombination Repair Gene Mutations by Tumor Tissue and Circulating Tumor DNA Testing in Prostate Cancer in the Phase III PROpel Trial. (PubMed, JCO Precis Oncol)
    Aggregating tumor tissue and ctDNA analyses maximized the number of patients (98%) with known biomarker status in PROpel while limiting the number of potential false negatives. This represents the most comprehensive means for identifying biomarker-positive and biomarker-negative subgroups and demonstrates the complementary utility of ctDNA testing in mCRPC, particularly when tissue testing is unable to provide a clinically useful result.
    Clinical • P3 data • Journal • BRCA Biomarker • PARP Biomarker • Circulating tumor DNA
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
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    FoundationOne® CDx • FoundationOne® Liquid CDx
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    Lynparza (olaparib) • abiraterone acetate • prednisone
    1m
    COPERNIC: A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients (clinicaltrials.gov)
    P=N/A, N=103, Active, not recruiting, Jules Bordet Institute | Trial primary completion date: Apr 2026 --> Sep 2026
    Trial primary completion date • Circulating tumor DNA
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    1m
    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
    2ms
    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
    |
    Guardant360® CDx • FoundationOne® Liquid CDx
    |
    Keytruda (pembrolizumab)
    2ms
    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
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Keytruda (pembrolizumab)
    2ms
    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
    |
    Lynparza (olaparib)