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    TEST:
    FoundationOne® Liquid CDx

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    10d
    Comprehensive molecular landscape of anal squamous cell carcinoma: analysis of tissue and liquid biopsies from 1844 patients. (PubMed, NPJ Precis Oncol)
    Four clinical examples illustrated LB-guided therapies. This largest-to-date aSCC cohort reinforces molecular profiling-especially LB-as a key tool for guiding personalized therapy.
    Journal • Liquid biopsy • Tumor mutational burden • BRCA Biomarker
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • NRAS (Neuroblastoma RAS viral oncogene homolog) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • PTEN (Phosphatase and tensin homolog) • KMT2D (Lysine Methyltransferase 2D) • FBXW7 (F-Box And WD Repeat Domain Containing 7)
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    TP53 mutation • EGFR mutation • TMB-H • BRAF mutation • NRAS mutation • PIK3CA mutation • PTEN mutation • FGFR2 mutation
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    16d
    Genomic alteration and clinical significance of circulating tumor DNA in patients with advanced urothelial cancer: SCRUM-Japan monstar screen project. (PubMed, NPJ Precis Oncol)
    A total of 133 Japanese patients (SCRUM-Japan cohort) were analyzed, including serial ctDNA sampling before and after platinum-based chemotherapy or pembrolizumab...In contrast, concordance between tissue and ctDNA profiling was only 46%, with ctDNA identifying additional actionable mutations not detected in tissue. These findings underscore the potential of ctDNA as a non-invasive tool for dynamic molecular monitoring and prognostication in aUC, supporting its integration into clinical practice.
    Journal • PD(L)-1 Biomarker • Circulating tumor DNA
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    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • KMT2D (Lysine Methyltransferase 2D) • MLL2 (Myeloid/lymphoid or mixed-lineage leukemia 2)
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    FoundationOne® Liquid CDx
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    Keytruda (pembrolizumab)
    28d
    Longitudinal Circulating Tumor DNA Profiling as a Biomarker for Response and Resistance in Platinum-Refractory Head and Neck Squamous Cell Carcinoma. (PubMed, Cancer Res Treat)
    Patients with platinum-refractory HNSCC receiving nivolumab were enrolled...Serial ctDNA analysis provides a noninvasive tool for monitoring treatment response and detecting emerging resistance in HNSCC treated with ICIs. A significant reduction in ctDNA at 6 weeks was associated with improved clinical outcomes and warrants validation in larger, prospective studies to define its role as a predictive biomarker in HNSCC.
    Journal • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
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    TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • NOTCH1 (Notch 1) • CCND1 (Cyclin D1)
    |
    FoundationOne® Liquid CDx
    |
    Opdivo (nivolumab)
    1m
    A Case of Combined Small-cell Carcinoma and Adenocarcinoma of the Lung With EGFR Exon 19 Deletion Identified via Liquid Genomic Profiling. (PubMed, In Vivo)
    This case illustrates the clinical value of liquid biopsy in detecting actionable mutations in patients with mixed histological lung cancers where tissue-based testing is inconclusive. Liquid biopsy enabled a personalized therapeutic approach without the need for further invasive procedures. Such strategies may be essential in managing histologically and genomically heterogeneous tumors.
    Journal • IO biomarker
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    EGFR (Epidermal growth factor receptor)
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    EGFR exon 19 deletion • EGFR wild-type
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    FoundationOne® Liquid CDx
    |
    Tagrisso (osimertinib)
    1m
    Current status and issues regarding genetic medicine after cancer gene panel testing in Japanese patients with metastatic prostate cancer. (PubMed, Mol Clin Oncol)
    Cancer genetic medicine offers clinical benefits for patients with metastatic prostate cancer; however, most patients do not receive GMT after CGP testing. The implementation of genetic counseling for cancer susceptibility genes is thus insufficient and requires improvement.
    Journal
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    1m
    A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) (clinicaltrials.gov)
    P3, N=1050, Recruiting, Hoffmann-La Roche | Trial primary completion date: Jul 2026 --> Feb 2027
    Trial primary completion date
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
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    ER positive • HER-2 negative • ESR1 mutation • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    FoundationOne® Liquid CDx
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    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • giredestrant (RG6171)
    2ms
    TALAPRO-3: Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC (clinicaltrials.gov)
    P3, N=599, Active, not recruiting, Pfizer | Trial primary completion date: Sep 2025 --> Feb 2026
    Trial primary completion date
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Talzenna (talazoparib) • Xtandi (enzalutamide)
    2ms
    Factors Associated with the Detection of Actionable Genomic Alterations Using Liquid Biopsy in Biliary Tract Cancer. (PubMed, Cancers (Basel))
    F1L detection increased from 5.8% (zero factors) to 32.8% (four factors), approximating tissue at three factors. The utility of liquid biopsy can be maximized by carefully selecting samples on the basis of conditions that increase the detection rate.
    Journal • Liquid biopsy • MSi-H Biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • NTRK (Neurotrophic receptor tyrosine kinase)
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    BRAF V600E • KRAS mutation • TMB-H • MSI-H/dMMR • KRAS G12C • HER-2 amplification • BRAF V600 • HER-2 mutation • IDH1 mutation • RET fusion • FGFR2 mutation • FGFR2 fusion • KRAS G12 • IDH mutation + BRAF V600E • IDH mutation + NTRK fusion • NTRK fusion
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    FoundationOne® Liquid CDx
    2ms
    PREDiCTl: PRecision Oncology Evidence Development in Cancer Treatment - Liquid (clinicaltrials.gov)
    P=N/A, N=1500, Active, not recruiting, British Columbia Cancer Agency | Trial completion date: Jun 2025 --> Jun 2027 | Trial primary completion date: Jun 2025 --> Jun 2027
    Trial completion date • Trial primary completion date • Real-world evidence • Circulating tumor DNA
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    FoundationOne® Liquid CDx
    2ms
    SPARK: Studying Pathways of Resistance in KRAS-driven Cancers (clinicaltrials.gov)
    P=N/A, N=500, Active, not recruiting, Addario Lung Cancer Medical Institute | Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Mar 2026
    Enrollment closed • Trial completion date
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    KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation • KRAS G12C • KRAS G12
    |
    FoundationOne® Liquid CDx
    3ms
    The diagnostic accuracy of next-generation sequencing in advanced NSCLC. (PubMed, J Liq Biopsy)
    The PPA for bTMB was 31·3 % for ctDNA TF low and 92·3 % for ctDNA TF high, with negative percent agreement (NPA) at 100 % and 85·6 %, respectively. In the context of high ctDNA TF, blood-based TP-NGS can detect clinically actionable mutations and may effectively replace tissue biopsies when obtaining tumor tissue is impractical.
    Journal • Next-generation sequencing • Tumor mutational burden
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    EGFR (Epidermal growth factor receptor) • TMB (Tumor Mutational Burden)
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    EGFR mutation
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    3ms
    Prediction System for KRAS Mutation Detection in Circulating Tumor DNA in Unresectable Pancreatic Cancer. (PubMed, Anticancer Res)
    Our prediction system effectively stratified patients by the likelihood of KRAS mutation detection, offering a practical tool for selecting candidates for liquid biopsy. These findings underscore the importance of personalized approaches in unresectable PC management and suggest that patients without these key clinical factors may not benefit from ctDNA testing. Future studies should validate this model in larger cohorts.
    Retrospective data • Journal • Circulating tumor DNA
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    KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation
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    Guardant360® CDx • FoundationOne® Liquid CDx