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TEST:
FoundationOne® CDx

Company:
Roche
Type:
FDA Approved (PMA)
Related tests:
4d
Homologous recombination repair status in advanced endometrial cancer: an exploratory biomarker analysis from the randomized, phase II MITOEND 3 trial. (PubMed, ESMO Open)
A small subgroup of advanced EC patients shows HRD positivity by gLOH or HRDsig, potentially identifying those most likely to benefit from PARP inhibitors. These tumors are typically endometrioid with TP53 mutations.
P2 data • Journal • MSi-H Biomarker • PARP Biomarker • PD(L)-1 Biomarker
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TP53 (Tumor protein P53) • MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
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TP53 mutation • MSI-H/dMMR • HRD
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FoundationOne® CDx
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Bavencio (avelumab)
10d
Comprehensive genomic profiling for homologous recombination deficiency guides PARP inhibitor therapy recommendations in ovarian cancer. (PubMed, Pathol Oncol Res)
PARPi selection differed by HRD status, with niraparib favored in HR-proficient and olaparib in HRD-positive tumors. No additional profiling was required for PARPi therapy recommendation, and no incidental findings beyond the scope of HRD testing were detected. Molecular profiling with F1CDx proved to be a technically feasible, clinically impactful, and time-efficient assay, demonstrating its value in supporting molecular-guided PARPi therapy recommendations in the routine care of HGSOC patients.
Retrospective data • Journal • BRCA Biomarker • PARP Biomarker
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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HRD • BRCA mutation
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FoundationOne® CDx
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Lynparza (olaparib) • Zejula (niraparib)
14d
Predictive molecular alterations of prostate cancer brain metastases based on a companion diagnostic assay. (PubMed, Discov Oncol)
The current first-line treatment standard for patients with metastatic prostate cancer (mPCa), is a combination of androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI), plus the addition of docetaxel for fit patients with high-volume or high-risk disease...Additionally, we found 7/44 patients (15.9%) qualifying for immune check-point inhibitors therapy. We anticipate that these findings will improve the rate of molecular testing in mCRPC patients with brain metastases and advance personalized management of these patients.
Journal • Diagnostic assay • Companion diagnostic • BRCA Biomarker • PARP Biomarker • BRCA Companion diagnostic • PARP Companion diagnostic
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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
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docetaxel
15d
Exceptional Response to Trastuzumab Deruxtecan (T-DXd) in HER2-Positive Metastatic Endometrial Cancer. (PubMed, Curr Oncol)
She received carboplatin/paclitaxel plus avelumab, followed by pegylated liposomal doxorubicin and weekly paclitaxel. This case illustrates that T-DXd can induce deep and durable remission in HER2-positive, dMMR metastatic serous endometrial cancer after multiple lines of therapy. It adds real-world evidence supporting further investigation of HER2-directed antibody-drug conjugates in gynaecologic malignancies, and underscores the need for confirmatory trials and refined biomarker-driven patient selection.
Journal • PD(L)-1 Biomarker
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HER-2 (Human epidermal growth factor receptor 2) • MUC16 (Mucin 16, Cell Surface Associated)
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HER-2 positive • MSI-H/dMMR • HER-2 overexpression • HER-2 positive + HER-2 overexpression
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FoundationOne® CDx
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carboplatin • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • Bavencio (avelumab) • pegylated liposomal doxorubicin
16d
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
19d
A signal-seeking phase 2 study of tremelimumab in advanced cancers with high tumour mutational burden. (PubMed, NPJ Precis Oncol)
Seven tremelimumab-related serious adverse events (grade 2-3) occurred in 5 patients. While the primary PFS6 endpoint was not met, there were two durable objective responses in rare cancers and a favourable change in disease trajectory for an additional five patients based on TTP ratio 1.3.
P2 data • Journal • Tumor mutational burden
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TMB (Tumor Mutational Burden)
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TMB-H
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FoundationOne® CDx • TruSight Oncology 500 Assay • TruSight Tumor 170 Assay
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Imjudo (tremelimumab-actl)
21d
Coverage of Actionable Alterations In Non-Small Cell Lung Cancer by Hybrid Capture-Based FoundationOne®CDx Compared With Amplicon-based Oncomine™ DX. (PubMed, Oncologist)
In summary, in advanced NSCLC, hybrid capture-based NGS, such as F1CDx, may capture more actionable genomic alterations as compared with ODxTT, an amplicon-based NGS.
Journal • Tumor mutational burden • MSi-H Biomarker
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
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KRAS mutation • EGFR mutation • MSI-H/dMMR • KRAS G12C • MET mutation • KRAS G12
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FoundationOne® CDx • Oncomine™ Dx Target Test
22d
Use of Serial Plasma NGS as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation (clinicaltrials.gov)
P=N/A, N=39, Active, not recruiting, Massachusetts General Hospital | Recruiting --> Active, not recruiting
Enrollment closed • IO biomarker
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FoundationOne® CDx
24d
Analytical validation of a homologous recombination deficiency signature (HRDsig) in pan-tumor tissue samples. (PubMed, PLoS One)
HRDsig status remained consistent in the presence of interfering substances, demonstrating 100% concordance in spiked samples. These validation results underscore the high analytical concordance, low false-positive rate, and overall robustness of HRDsig for reliable assessment of homologous recombination deficiency.
Journal • PARP Biomarker • Pan tumor
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HRD (Homologous Recombination Deficiency)
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HRD
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FoundationOne® CDx
24d
A tough NUT carcinoma to crack. (PubMed, Pathologica)
IHC and molecular results all together are suggestive for a likely non-canonical BRD4-NUTM1 fusion. Our case showed unusual features both from a morphological and a molecular point of view: the diagnosis was driven by NUT1 positive immunohistochemistry, thus underlining the crucial role of this test.
Journal
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NKX2-1 (NK2 Homeobox 1) • BRD4 (Bromodomain Containing 4) • NUTM1 (NUT Midline Carcinoma Family Member 1)
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FoundationOne® CDx
27d
Lung adenocarcinoma with ALK deletion of exons 6-20 with response to sequential ALK inhibitors: a case report. (PubMed, Transl Lung Cancer Res)
Herein, we report a case of lung adenocarcinoma harboring ALK deletions of exons 6-20 that responded to alectinib and lorlatinib treatment...Despite the high expression of programmed death ligand 1 (PD-L1) (tumor proportion score: 95%), the response to pembrolizumab and chemotherapy was limited...This case suggests that ALK internal deletions, even those affecting exon 20, demonstrate oncogenic potential and sensitivity to ALK inhibitors. ALK IHC remains an essential complementary test in cases of high clinical suspicion and inconclusive results using initial molecular testing.
Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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PD-L1 expression • ALK rearrangement
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FoundationOne® CDx • AmoyDx® Pan Lung Cancer PCR Panel
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Keytruda (pembrolizumab) • Alecensa (alectinib) • Lorbrena (lorlatinib)
1m
Analysis of comprehensive genomic profiling test for Ewing sarcoma in pediatric patients and adults using the nationwide clinical and genomic database in Japan. (PubMed, Jpn J Clin Oncol)
Compared to previous reports, Japanese ES cases showed lower STAG2 and higher TP53 mutation frequencies. CDKN2A and CDKN2B deletions may serve as prognostic biomarkers indicating unfavorable outcomes.
Journal
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TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • EWSR1 (EWS RNA Binding Protein 1) • STAG2 (Stromal Antigen 2)
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TP53 mutation • CDKN2A deletion
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FoundationOne® CDx • MSK-IMPACT