^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners

    TEST:
    FoundationOne® Liquid CDx

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    11d
    Liquid Biopsy in Ewing Sarcoma and Osteosarcoma as a Prognostic And Response Diagnostic: LEOPARD (clinicaltrials.gov)
    P=N/A, N=340, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date • Liquid biopsy
    |
    FoundationOne® Liquid CDx
    19d
    Emergence of BRCA Reversion Mutations in Prostate Cancer Prior to PARP Inhibitor Exposure: Clinical and Therapeutic Implications. (PubMed, Cancer Med)
    BRCArev can emerge in PCA in the absence of prior PARPi therapy, particularly following exposure to cytotoxic chemotherapy and radiation. These findings support that DNA-damaging therapies may promote BRCArev formation, potentially predisposing to primary PARPi resistance. Early integration of PARPi therapy before chemotherapy may enhance clinical benefit and circumvent emergence of primary resistance.
    Retrospective data • Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    FoundationOne® Liquid CDx
    |
    Lynparza (olaparib) • docetaxel
    21d
    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, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date • Tumor mutational burden
    |
    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)
    |
    PALB2 mutation • BRIP1 mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Lynparza (olaparib)
    24d
    Quantitative ctDNA Profiling of RAS Mutations as a Prognostic Biomarker in Metastatic Colorectal Cancer. (PubMed, Int J Mol Sci)
    High RAS VAF in ctDNA is a strong and independent prognostic marker for OS in mCRC. Quantitative ctDNA profiling may enhance risk stratification and guide personalized management strategies.
    Retrospective data • Journal • Tumor mutational burden • Circulating tumor DNA
    |
    BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • RAS (Rat Sarcoma Virus)
    |
    BRAF V600E • BRAF V600 • BRAF wild-type • RAS mutation
    |
    FoundationOne® Liquid CDx
    24d
    Genetic Landscape of Solid Malignant Tumors in a Russian Cohort of Patients. (PubMed, Diagnostics (Basel))
    This study reveals the distinct genomic characteristics of solid tumors in a Russian cohort and confirms the high clinical utility of CGP for identifying actionable targets. Implementing CGP early in the diagnostic process is a necessary step towards realizing personalized treatment strategies for cancer patients.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • APC (APC Regulator Of WNT Signaling Pathway)
    |
    PD-L1 expression • TP53 mutation • KRAS mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    24d
    Genomic landscape of metastatic breast cancers in young adults: a liquid biopsy analysis of women aged 20-40 years. (PubMed, Breast)
    ESCAT tiers I-III alterations were reported in 79 % YA with MBC which supports the role of molecular profiling in YA. The differences detected in the genomic profiles of YA with BC and older patients may allude to potential different underlying disease biology.
    Journal • Liquid biopsy • BRCA Biomarker
    |
    ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • FGFR3 (Fibroblast growth factor receptor 3) • RB1 (RB Transcriptional Corepressor 1) • CCND1 (Cyclin D1) • FGF19 (Fibroblast growth factor 19) • FGFR4 (Fibroblast growth factor receptor 4) • STING (stimulator of interferon response cGAMP interactor 1)
    |
    HR positive • PTEN mutation
    |
    FoundationOne® Liquid CDx
    27d
    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 | Recruiting --> Active, not recruiting
    Enrollment closed • Circulating tumor DNA
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    1m
    Cetuximab rechallenge in molecularly selected metastatic colorectal cancer: the randomized CAVE-2 GOIM trial. (PubMed, Ann Oncol)
    Addition of avelumab does not increase efficacy of cetuximab rechallenge. Liquid biopsy CGP identifies patients that benefit of anti-EGFR rechallenge supporting its implementation in the continuum of care of mCRC. (Clinical trial number: NCT05291156).
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • PTEN (Phosphatase and tensin homolog) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    EGFR exon 20 insertion • BRAF wild-type
    |
    FoundationOne® Liquid CDx
    |
    Erbitux (cetuximab) • Bavencio (avelumab)
    2ms
    L1st: A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer (clinicaltrials.gov)
    P=N/A, N=463, Completed, Hoffmann-La Roche | Phase classification: P4 --> P=N/A
    Phase classification • Liquid biopsy
    |
    NKX2-1 (NK2 Homeobox 1) • NAPSA (Napsin A Aspartic Peptidase)
    |
    FoundationOne® Liquid CDx
    2ms
    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
    |
    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)
    |
    TP53 mutation • EGFR mutation • TMB-H • BRAF mutation • NRAS mutation • PIK3CA mutation • PTEN mutation • FGFR2 mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    3ms
    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
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • KMT2D (Lysine Methyltransferase 2D) • MLL2 (Myeloid/lymphoid or mixed-lineage leukemia 2)
    |
    FoundationOne® Liquid CDx
    |
    Keytruda (pembrolizumab)
    3ms
    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
    |
    TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • NOTCH1 (Notch 1) • CCND1 (Cyclin D1)
    |
    FoundationOne® Liquid CDx
    |
    Opdivo (nivolumab)