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

    TEST:
    FoundationOne® CDx

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    18d
    Prevalence and complementary distribution of FGFR3 alterations and ERBB2 amplification in metastatic urothelial carcinoma: a nationwide registry analysis. (PubMed, Int J Clin Oncol)
    In this nationwide metastatic cohort, FGFR3 alterations and ERBB2 amplification were each detected in approximately 15% of cases and showed a significant but partial negative association. These findings clarify the molecular epidemiology of mUC and support comprehensive genomic profiling to guide biomarker-driven therapy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3)
    |
    HER-2 positive • HER-2 amplification
    |
    FoundationOne® CDx
    18d
    Tumour Mutational Burden and Its Relationship with Clinical Outcomes in Locally Advanced and Recurrent/Metastatic Adenoid Cystic Carcinoma with and Without NOTCH Pathway Activation. (PubMed, Cancers (Basel))
    LA-R/M ACC has a low TMB profile overall. Median TMB was higher in NOTCH-activated ACC in both the NHS and MSK groups and TMB may have value in further stratifying patients with LA-R/M ACC.
    Clinical data • Journal • Tumor mutational burden
    |
    TMB (Tumor Mutational Burden) • NOTCH1 (Notch 1) • NOTCH2 (Notch 2)
    |
    TMB-L
    |
    FoundationOne® CDx • MSK-IMPACT
    20d
    Technical evaluation of commercially available homologous recombination deficiency assays using MyChoice CDx as reference in ovarian cancer. (PubMed, Gynecol Oncol)
    Using MyChoice CDx as reference, commercially available assays showed concordance in detecting HRD, genomic instability, and BRCA mutations, indicating their potential clinical utility in identifying appropriate treatment options for ovarian cancer.
    Journal • BRCA Biomarker
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    FoundationOne® CDx • Myriad myChoice® CDx • Oncomine™ Comprehensive Assay Plus • SOPHiA DDM HRD Solution
    20d
    Distinct molecular and clinical aggressiveness in very early-onset metastatic colorectal cancer: survival and genomic divergence between patients aged 30-39 versus 40-49 years. (PubMed, ESMO Open)
    Patients aged 30-39 years constitute a biologically distinct subgroup within EOCRC, with shorter survival, KRAS mutation enrichment, fewer APC alterations, and increased peritoneal involvement. These findings support the emerging idea of an 'ultra-young', genomically driven CRC subtype, with implications for disease biology, risk assessment, and treatment development.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • PTEN (Phosphatase and tensin homolog)
    |
    KRAS mutation
    |
    FoundationOne® CDx
    23d
    Earlier Comprehensive Cancer Genomic Profiling in Gynecologic Cancers May Facilitate Genotype-Matched Therapy: A Prospective Single-Institution Study. (PubMed, Obstet Gynecol Int)
    In survival analysis using the Cox proportional hazards model, the presence of PIK3CA mutations was identified as being potentially associated with adverse prognosis (hazard ratio: 2.73, 95% confidence interval: 1.15-6.49, and p = 0.023). To enhance the prognosis of gynecologic cases, earlier CGP testing to expand the opportunities for GMT and the proactive introduction of PIK3CA-related clinical trials might be crucial.
    Journal
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    1m
    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
    |
    MSI (Microsatellite instability) • CA 19-9 (Cancer antigen 19-9)
    |
    MSI-H/dMMR
    |
    FoundationOne® CDx
    |
    Keytruda (pembrolizumab)
    1m
    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
    |
    RET (Ret Proto-Oncogene)
    |
    RET fusion • RET positive
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    1m
    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
    |
    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
    |
    Lynparza (olaparib)
    1m
    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
    |
    TMB (Tumor Mutational Burden)
    |
    TMB-L
    |
    FoundationOne® CDx
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    1m
    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
    |
    FoundationOne® CDx
    |
    Itovebi (inavolisib)
    1m
    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
    |
    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)
    |
    PIK3CA mutation • ARID1A mutation
    |
    FoundationOne® CDx
    1m
    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
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Talzenna (talazoparib)