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TEST:
FoundationOne® Liquid CDx

Company:
Roche
Type:
FDA Approved (PMA)
Related tests:
1d
Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. (clinicaltrials.gov)
P1/2, N=40, Active, not recruiting, Criterium, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Aug 2024 --> Mar 2026
Enrollment closed • Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CD4 (CD4 Molecule)
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HER-2 positive • PIK3CA mutation
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Guardant360® CDx • FoundationOne® Liquid CDx • therascreen® PIK3CA RGQ PCR Kit
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Piqray (alpelisib) • fulvestrant • Tukysa (tucatinib)
5d
Enrollment open
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 mutation • ESR1 mutation
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FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx
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everolimus • dexamethasone • Orserdu (elacestrant)
5d
Real-world insights from comprehensive genomic profiling in patients with metastatic castration-resistant prostate cancer. (PubMed, Jpn J Clin Oncol)
CGP identified BRCA PVs, MSI-high, or TMB-high in 20% of patients with metastatic CRPC, supporting its value in guiding precision oncology. However, only some patients received matched therapy, supporting earlier CGP testing. Routine integration of CGP may facilitate precision oncology-guided treatment decision-making in this population.
Journal • Real-world evidence • Tumor mutational burden • BRCA Biomarker • MSi-H Biomarker • PD(L)-1 Biomarker
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • BRCA (Breast cancer early onset)
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TMB-H • MSI-H/dMMR
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FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
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Keytruda (pembrolizumab)
19d
Assessing the Impact of Comprehensive Genomic Profiling on Therapeutic Selection for Advanced Solid Tumors in Portugal. (PubMed, Curr Oncol)
The FRONTAL study highlighted the clinical relevance of CGP in advanced solid tumors. Over half of the patients had actionable alterations, a quarter had therapy changes based on CGP results, and improved disease outcome was observed in approximately 15% of the cohort.
Journal
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FoundationOne® CDx • FoundationOne® Liquid CDx • FoundationOne® Heme CDx
28d
Detection of a Rare Intra-ALK Inversion and ALK Rearrangement in a Lung Adenocarcinoma Patient by FoundationOne Liquid CDx and Successful Treatment with Alectinib: Case Report. (PubMed, JTO Clin Res Rep)
This case highlights the value of next-generation sequencing-based profiling in detecting rare actionable alterations missed by standard tests. We also include a discussion on why the EML4-AKL fusion was not detected in the usual test.
Journal • IO biomarker
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ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4)
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ALK rearrangement
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FoundationOne® Liquid CDx • Oncomine™ Dx Target Test
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Alecensa (alectinib)
29d
Prognostic significance of tumor fraction in advanced sarcoma: highlighting a novel circulating biomarker. (PubMed, Clin Exp Med)
Our findings demonstrate that ctDNA TF provides non-invasive, real-time prognostic information in this rare and heterogeneous tumor type, with potential applications for patient stratification, treatment planning, and clinical trial design. Prospective validation is warranted to define standardized TF thresholds and support its integration into sarcoma care.
Journal
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STING (stimulator of interferon response cGAMP interactor 1)
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FoundationOne® Liquid CDx
1m
Prediction model for ctDNA detectability in liquid comprehensive genomic profiling of advanced pancreatic cancer based on Japanese real-world data. (PubMed, ESMO Open)
This prediction model enables accurate pre-test estimation of ctDNA detectability in advanced pancreatic cancer and may enhance the clinical utility of liquid CGP by informing optimal test selection and timing.
Journal • Real-world evidence • Circulating tumor DNA
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FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx
1m
Prognostic Impact of Blood Tumor Mutational Burden in pMMR/MSS Metastatic Colorectal Cancer Assessed by FoundationOne® Liquid CDx. (PubMed, Cancers (Basel))
These results contrast with prior tissue-based studies and indicate that bTMB may reflect tumor burden and aggressive disease biology rather than tumor immunogenicity. Prospective studies integrating bTMB with ctDNA fraction, tumor burden metrics, and longitudinal molecular dynamics are warranted to refine its clinical utility.
Journal • Tumor mutational burden • pMMR
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BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • RAS (Rat Sarcoma Virus)
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BRAF V600E • TMB-H • BRAF V600 • BRAF wild-type • TMB-L • RAS mutation
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FoundationOne® Liquid CDx
1m
A comprehensive clinical trajectory of EGFR A763_Y764insFQEA-positive non-small cell lung cancer treated with fifth-line osimertinib following circulating tumor DNA-based detection: a case report. (PubMed, Transl Lung Cancer Res)
A 63-year-old Japanese woman with stage IVB lung adenocarcinoma [programmed death ligand-1 (PD-L1) tumor proportion score 70%] received multiple lines of systemic therapy, including pembrolizumab-based chemoimmunotherapy, docetaxel plus ramucirumab, and subsequent cytotoxic regimens. The A763_Y764insFQEA mutation is uniquely sensitive to EGFR-TKIs, and comprehensive molecular testing can guide effective targeted therapy even in later treatment lines. Broader implementation of hybrid-capture-based assays may improve precision oncology outcomes for patients with rare EGFR alterations.
Journal • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
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EGFR mutation • EGFR exon 20 insertion • EGFR A763_Y764insFQEA • EGFR exon 20 mutation
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FoundationOne® Liquid CDx
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Keytruda (pembrolizumab) • Tagrisso (osimertinib) • docetaxel • Cyramza (ramucirumab) • simmitinib (SYHA1817)
1m
Early-onset enriches the identification of actionable alterations in patients with KRAS wild-type pancreatic ductal adenocarcinoma. (PubMed, ESMO Gastrointest Oncol)
Notably, actionable gene fusions were found to be significantly enriched in KRAS-wt EO-PDACs compared with LO counterparts (4 versus 1, or 36.4% versus 2.4%, P = 0.005). KRAS-wt PDAC diagnosed at a younger age more frequently harbors actionable mutations, highlighting the importance of comprehensive genomic profiling to guide targeted therapeutic interventions in this patient population.
Journal
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KRAS (KRAS proto-oncogene GTPase)
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KRAS wild-type • RAS wild-type
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FoundationOne® CDx • FoundationOne® Liquid CDx
1m
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) (clinicaltrials.gov)
P1, N=542, Recruiting, Hoffmann-La Roche | Trial completion date: Nov 2028 --> Aug 2030 | Trial primary completion date: Aug 2027 --> Aug 2030
Trial completion date • Trial primary completion date
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FoundationOne® Liquid CDx
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Avastin (bevacizumab) • Erbitux (cetuximab) • Tecentriq (atezolizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • divarasib (RG6330) • Itovebi (inavolisib) • SY-5609 • tiragolumab (RG6058)
2ms
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
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FoundationOne® Liquid CDx