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    TEST:
    FoundationOne® CDx

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    4d
    Paradoxical hyperprogressive disease in MSI-high intrahepatic cholangiocarcinoma treated with pembrolizumab. (PubMed, Clin J Gastroenterol)
    This case highlights the paradoxical response to ICIs in ICC, demonstrating that MSI-H status does not preclude HPD. Further investigation of the tumor immune microenvironment is warranted.
    Journal • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • MSI-H
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    MSI (Microsatellite instability) • CA 19-9 (Cancer antigen 19-9)
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    MSI-H/dMMR
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    FoundationOne® CDx
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    Keytruda (pembrolizumab)
    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
    7d
    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, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Enrollment closed • 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
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    Lynparza (olaparib)
    10d
    Significant Response to Nivolumab Plus Ipilimumab in Metastatic Mucinous Tubular and Spindle Cell Carcinoma: A Case Report. (PubMed, IJU Case Rep)
    No disease progression was observed at 9 months. This case demonstrates the potential efficacy of combination immunotherapy in aggressive metastatic MTSCC.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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    TMB (Tumor Mutational Burden)
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    TMB-L
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    FoundationOne® CDx
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    Opdivo (nivolumab) • Yervoy (ipilimumab)
    17d
    U.S. Food and Drug Administration Approves FoundationOne CDx as a Companion Diagnostic for Itovebi (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation (Yahoo Finance)
    "Itovebi is a therapy developed by Genentech, a member of the Roche group, which is approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy."
    FDA approval
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    FoundationOne® CDx
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    Itovebi (inavolisib)
    17d
    Genetic mutations in metastatic adenocarcinoma of unknown primary. (PubMed, Otolaryngol Pol)
    GNAS and PIK3CA mutations were linked to favorable outcomes, while ARID1A and NOTCH1 alterations indicated poor prognosis in ACUP. These results highlight the prognostic significance of specific genomic alterations and support integrating CGP into the clinical management of ACUP.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • STK11 (Serine/threonine kinase 11) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ARID1A (AT-rich interaction domain 1A) • NOTCH1 (Notch 1) • KMT2D (Lysine Methyltransferase 2D) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • NOTCH3 (Notch Receptor 3) • GNAS (GNAS Complex Locus)
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    PIK3CA mutation • ARID1A mutation
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    FoundationOne® CDx
    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)
    20d
    Pan-tumor validation of FoundationOne®CDx as a companion diagnostic for RET fusions as a predictor of response to selpercatinib. (PubMed, Front Oncol)
    Demonstrated analytical and clinical performance of F1CDx led to the pan-tumor approvals from the U.S. Food and Drug Administration (FDA) in 2023 and the Japan Ministry of Health, Labour and Welfare (MHLW) in 2024 of F1CDx to identify RET fusions in solid tumor patients for treatment with selpercatinib. F1CDx is an accurate, reliable, FDA- and MHLW-approved method for the pan-tumor identification of RET fusions for treatment with selpercatinib.
    Journal • Companion diagnostic • Pan tumor
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    RET (Ret Proto-Oncogene)
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    RET fusion
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    FoundationOne® CDx
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    Retevmo (selpercatinib)
    22d
    Differences Among Genomic Profiling Tests for Bone and Soft-Tissue Sarcomas in a Universal Health Insurance System. (PubMed, J Bone Joint Surg Am)
    In this cohort, the DNA+RNA-based panel showed a higher detection rate for TK fusions, although the panels were applied to different patient groups and the sensitivity and specificity could not be determined. Future studies evaluating different test types on the same tumor specimens are warranted to clarify whether the dual-sequencing approaches can improve the identification of actionable genetic events.
    Reimbursement • US reimbursement • Journal
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    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • EML4 (EMAP Like 4) • FGFR1 (Fibroblast growth factor receptor 1) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NTRK (Neurotrophic receptor tyrosine kinase) • RBPMS (RNA-binding protein with multiple splicing)
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    ALK fusion • NTRK fusion
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
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    Vitrakvi (larotrectinib) • Rozlytrek (entrectinib)
    23d
    A CASE OF CASTRATION-RESISTANT PROSTATE CANCER ASSOCIATED WITH HEREDITARY BREAST-OVARIAN CANCER SYNDROME SHOWING LONG-TERM RESPONSE TO A POLY-ADP RIBOSE POLYMERASE INHIBITOR (PubMed, Hinyokika Kiyo)
    Five years later, progression to castration-resistant prostate cancer was confirmed, and abiraterone treatment was started...Treatment with docetaxel was initiated...The patient was started on olaparib, a poly (ADP-ribose) polymerase inhibitor. To date, his PSA level has remained below 0.001 ng/ml. He has been taking the medication for more than 42 months without any side effects, and imaging studies have consistently shown a complete response.
    Journal • BRCA Biomarker • PARP Biomarker
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    BRCA2 (Breast cancer 2, early onset)
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    FoundationOne® CDx
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    Lynparza (olaparib) • docetaxel • abiraterone acetate
    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