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

    TEST:
    OncoGuide™ NCC Oncopanel System

    Company:
    Sysmex Corp
    Type:
    Other Approval
    Related tests:
    Details
    Evidence

    News

    1m
    An approach for improvement of the accuracy of cancer gene panel testing. (PubMed, Int J Clin Oncol)
    We identified various factors associated with efficient and accurate CGP testing using relevant information obtained from real-world data, suggesting that thorough selection and preparation of tissue sections could optimize CGP and maximize useful information.
    Journal
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    2ms
    Incidence of pathogenic germline variants and presumed germline pathogenic variants in Japanese lung cancer patients using comprehensive genomic profiling tests (AACR 2024)
    The incidence of PGV in NOP and PGPV in F1L and F1CDx were 4/321 (1.2%), 36/773 (4.7%), and 141/2145 (6.6%), respectively (NOP vs F1L vs F1CDx; p = 0.001 NOP vs F1L; p = 0.006, NOP vs F1CDx; p < 0.001, F1L vs F1CDx; p=0.190). The 4 PGVs detected by NOP were in the ATM, BRCA2, MSH6, and TP53 genes. Notably, two out of four patients were in their 30s while the other two were in their 70s.
    Clinical • BRCA Biomarker
    |
    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2) • MSH6 (MutS homolog 6) • CHEK2 (Checkpoint kinase 2)
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    2ms
    Clinical significance of cancer genome profiling tests for gastrointestinal cancer patients with liver metastasis (AACR 2024)
    In 52 cases, six cases (4 of SD cases and 2 of PR cases) was administered encorafenib-based chemotherapies based on BRAF gene mutation... Around 13% of gastrointestinal cancer patients with liver metastasis might have a druggable benefit by CGP testing. BRAF mutation might be promising target for patients with liver metastasis. ZNF217, SRC, ARFRP1, BARD1, FGF10 might be associated with metastatic process to liver in gastrointestinal cancer.
    Clinical
    |
    BRAF (B-raf proto-oncogene) • BARD1 (BRCA1 Associated RING Domain 1) • ZNF217 (Zinc Finger Protein 217) • FGF10 (Fibroblast Growth Factor 10)
    |
    BRAF mutation • BARD1 mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    |
    Braftovi (encorafenib)
    2ms
    Use of artificial intelligence to facilitate reporting of comprehensive genomic profiling tests (AACR 2024)
    Chrovis-generated CGP reports did not require any changes in 82%s, suggesting that artificial intelligence reporting may lessen the burden of MTBs while contributing to its standardization. Recommendation for germline disclosure requires manual supervision, and improvements in clinical trial databases are required to correctly recommend genomically matched trials to patients.
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • NF1 (Neurofibromin 1) • SMAD4 (SMAD family member 4)
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    4ms
    Clinical Significance of Multi-Cancer Genome Profiling: Data from a Single Hospital in Japan. (PubMed, Cancer Genomics Proteomics)
    Of 230 patients, 21 were administered medication following multi-CGP testing data, especially frequent in biliary tumor patients. Multi-CGP testing might be particularly beneficial to patients with biliary tumors in Japan.
    Journal • BRCA Biomarker
    |
    BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    5ms
    Comprehensive genomic profiling of advanced anal adenocarcinoma. (ASCO-GI 2024)
    The present study showed that anal AD had a different profile of GAs compared with advanced rectal AD. CGP tests are useful tool for identifying druggable GAs in advanced anal AD for expanding therapeutic opportunities.
    Tumor mutational burden • MSi-H Biomarker • BRCA Biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • SMAD4 (SMAD family member 4)
    |
    BRAF V600E • KRAS mutation • BRCA2 mutation • TMB-H • MSI-H/dMMR • HER-2 amplification • BRAF V600 • KRAS G12D • KRAS G12 • BRAF amplification
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    5ms
    Genomic characterization of unresectable/recurrent early-onset gastric cancer by comprehensive genomic profiling tests. (ASCO-GI 2024)
    Among unresectable/recurrent GC population, EOCG has displayed distinct genetic profiles of GAs compared to LOGC. CGP tests may be useful in expanding treatment opportunities for patients with unresectable/recurrent EOGC.
    Tumor mutational burden • MSi-H Biomarker
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ARID1A (AT-rich interaction domain 1A) • CCNE1 (Cyclin E1) • MDM2 (E3 ubiquitin protein ligase) • BAP1 (BRCA1 Associated Protein 1) • CDH1 (Cadherin 1) • AURKA (Aurora kinase A)
    |
    KRAS mutation • EGFR mutation • TMB-H • MSI-H/dMMR • KRAS G12C • HER-2 amplification • MET amplification • EGFR amplification • FGFR2 mutation • FGFR2 amplification • MDM2 amplification • KRAS G12 • KRAS amplification
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    5ms
    The Utility of Clinical Sequencing in the Diagnosis and Treatment of Soft Tissue Sarcomas; Real-World Database on Nationwide Database (AAOS 2024)
    Gounder showed thar CGP could lead to refinement or reassignment of 10.5% of diagnoses and 32% of the patients harbored potentially actionable alterations. In this study, 2.8% of patients were reclassified and the actionable gene mutations were found in 25% of the patients with sarcoma by the CGP. Although few patients could receive genotype-matched therapy, they could achieve relatively good control.
    Real-world evidence • Clinical • Tumor mutational burden • MSi-H Biomarker • MSi-H Companion diagnostic • Real-world
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • RB1 (RB Transcriptional Corepressor 1) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • BCOR (BCL6 Corepressor) • EWSR1 (EWS RNA Binding Protein 1) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor) • NTRK (Neurotrophic receptor tyrosine kinase) • DUX4 (Double Homeobox 4)
    |
    TMB-H • MSI-H/dMMR • NTRK1 fusion • NTRK3 fusion • ALK fusion • ROS1 fusion • NTRK fusion
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    6ms
    Results of Comprehensive Genomic Profiling of Metastatic Breast Cancer Patients at a Single Institute in Japan (SABCS 2023)
    Three HER2-negative patients were prescribed anti-HER2 therapy for ERBB2 amplification, one patient was prescribed entrectinib for NTRK fusion, and three patients participated in clinical trial for ERBB2 mutation and FGFR1 rearrangement. If ESCAT ranking beyond I/II and recommended therapy from FoundationOne report (e.g Abemaciclib for CCND1 amplification, Everolimus for PTEN loss)are added, 64 pts (60.1%) were considered these treatments, and 19 pts (18.1%) actually received these treatment...Low accessibility of ESCAT ranking I/II MT may be because, in Japan, CGP testing is available only for patients who have completed or are expected to complete standard therapy. Early use of CGP testing and an increase in clinical trials will be desirable in Japan.
    Clinical • Metastases
    |
    PTEN (Phosphatase and tensin homolog) • FGFR1 (Fibroblast growth factor receptor 1) • CCND1 (Cyclin D1) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    HER-2 amplification • HER-2 negative • FGFR1 mutation • CCND1 amplification • FGFR1 fusion • FGFR1 rearrangement • NTRK fusion
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    |
    Rozlytrek (entrectinib) • everolimus • Verzenio (abemaciclib)
    7ms
    Comparison of the novel Franseen needle versus the fine-needle aspiration needle in endoscopic ultrasound-guided tissue acquisition for cancer gene panel testing: A propensity score-matching analysis. (PubMed)
    Multivariate analysis revealed an association between TopGain and tissue areas of ≥4 mm (odds ratio 2.996, 95% confidence interval 1.068-8.403, P = 0.037). EUS-TA using TopGain significantly collected more ≥4 mm tissue area compared with EZ3, suggesting its usefulness for cancer gene panel testing.
    Journal
    |
    OncoGuide™ NCC Oncopanel System
    8ms
    Sysmex : OncoGuide NCC Oncopanel System Receives Insurance Coverage as a Companion Diagnostic for Futibatinib, a Treatment for Advanced Biliary Tract Cancer (Market Screener)
    "Sysmex Corporation...is now covered by health insurance in Japan as a companion diagnostic for futibatinib,1 a treatment for unresectable biliary tract cancer2 harboring FGFR2 gene fusions3 that has progressed after chemotherapy. Futibatinib was developed by Taiho Pharmaceutical Co., Ltd....Riken Genesis Co., Ltd (HQ: Shinagawa-ku, Tokyo, Japan; President: Kenji Iwakabe), a subsidiary of Sysmex, will begin assay services in Japan corresponding to this insurance coverage from September 2023."
    Reimbursement
    |
    OncoGuide™ NCC Oncopanel System
    |
    Lytgobi (futibatinib)
    8ms
    GENOMIC ALTERATIONS IN ADVANCED GASTROINTESTINAL STROMAL TUMORS AS REVEALED BY COMPREHENSIVE GENOMIC PROFILING TESTS (CTOS 2023)
    Fifty-four patients (38%) underwent CGP tests using specimens obtained before initiating treatment with imatinib and 90 (63%) using specimens obtained after imatinib. The present study highlights that approximately 25% and 50% of patients in each KIT/PDGFRA and wild-type group exhibit targetable GAs, thereby illustrating the clinical utility of CGP tests in identifying therapeutic targets in advanced GISTs.
    Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • BRCA Biomarker • Stroma • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • 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) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • STK11 (Serine/threonine kinase 11) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • RB1 (RB Transcriptional Corepressor 1) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • NF1 (Neurofibromin 1) • PALB2 (Partner and localizer of BRCA2) • ETV6 (ETS Variant Transcription Factor 6) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B) • TSC1 (TSC complex subunit 1) • SDHA (Succinate Dehydrogenase Complex Flavoprotein Subunit A)
    |
    TP53 mutation • BRAF V600E • TMB-H • MSI-H/dMMR • HER-2 amplification • BRAF V600 • NTRK3 fusion • STK11 mutation • ETV6-NTRK3 fusion • PDGFRA D842V • PDGFRA mutation • TSC1 mutation • PDGFR wild-type
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    |
    Keytruda (pembrolizumab) • Vitrakvi (larotrectinib) • Rozlytrek (entrectinib) • imatinib
    8ms
    Clinical availability and characteristics of multigene panel testing for recurrent/advanced gynecologic cancer. (PubMed, Int J Clin Oncol)
    Through multigene panel testing, although many patients had druggable gene alterations, 10.8% of them received the recommended treatment. TMB-H was mainly observed in cervical/endometrial cancer, suggesting its potential as a therapeutic biomarker of immune checkpoint inhibitors. Furthermore, patients' prognosis and performance status should be considered before performing the test.
    Journal • Tumor mutational burden • IO biomarker • Metastases
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • PTEN (Phosphatase and tensin homolog)
    |
    TMB-H • PIK3CA mutation • PTEN mutation • PIK3CA mutation + PTEN mutation
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    10ms
    Pediatric Precision Medicine at the National Cancer Center Japan: Prospective Genomic Study of Pediatric Patients with Cancer as Part of the TOP-GEAR Project. (PubMed, JCO Precis Oncol)
    The implementation of genomic medicine has furthered our understanding of tumor biology and provided new therapeutic strategies. However, the paucity of proposed agents limits the full potential of actionability, emphasizing the significance of facilitating access to targeted cancer therapies.
    Journal
    |
    TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • CDK4 (Cyclin-dependent kinase 4)
    |
    OncoGuide™ NCC Oncopanel System
    11ms
    Genetic characteristics of platinum-sensitive ovarian clear cell carcinoma. (PubMed, Jpn J Clin Oncol)
    The subset of platinum-sensitive ovarian clear cell carcinomas includes a majority with pure ovarian clear cell carcinoma features that lack the homologous recombination deficiency phenotype.
    Journal • BRCA Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency)
    |
    BRCA2 mutation • BRCA1 mutation • HRD • ATM mutation • HRD + BRCA1 mutation • BRCA1 mutation + BRCA2 mutation
    |
    Myriad myChoice® CDx Plus • OncoGuide™ NCC Oncopanel System
    11ms
    Clinical Outcomes of Comprehensive Genomic Profiling Tests for Gastrointestinal Cancers: Experience from Tokushima University Hospital. (PubMed, J Med Invest)
    Invest. 70 : 154-159, February, 2023.
    Journal • Clinical data
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • TruSight Oncology 500 Assay • OncoGuide™ NCC Oncopanel System
    12ms
    Trends in the needs and clinical utility of comprehensive genomic profiling test in rare cancers before and after the National Health Insurance coverage in Japan. (ASCO 2023)
    The use of CGP in the treatment of rare cancers under the national health insurance system has enabled us to expand the usage to a variety of disease groups, indicating a growing need.
    US reimbursement • Reimbursement • Clinical • BRCA Biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • FBXW7 (F-Box And WD Repeat Domain Containing 7)
    |
    OncoGuide™ NCC Oncopanel System
    12ms
    Actionability of comprehensive genomic profiling compared to the tissue-based and plasma-based assay in patients with metastatic breast cancer: A real-world study. (ASCO 2023)
    This study is the first analysis of CGP for mBC in Japan using the C-CAT utilization program. Although significant alterations were well-detected in PBA, the proportion of pts who received matched-therapy post-testing was low for PBA. Possible causes include that PBA has fewer companion diagnoses than TBA in Japan and that PBA is more often used in later lines.
    Real-world evidence • Clinical • Real-world • Metastases
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    1year
    Endoscopic Ultrasound-Guided Tissue Acquisition of Pancreaticobiliary Cancer Aiming for a Comprehensive Genome Profile. (PubMed, Diagnostics (Basel))
    Furthermore, cancer genome medicine is expected to enter an era of increasing turbulence in the future, and endoscopists need to respond flexibly to these changes. Herein, we review the current status of cancer genome medicine in pancreatic and biliary tract cancers and cancer gene panel testing using EUS-TA.
    Journal • Review
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    1year
    Real-world surveillance from cancer patients about their experience of comprehensive genomic profiling tests in Japan (AACR 2023)
    Our surveillance highlighted the significance of drug accessibility, information from interdisciplinary collaboration team, and appropriate information about the test results. The opportunity to learn about their cancer in detail was valuable for the patients as well, even when the results of CGP testing did not lead to a novel therapy.
    Real-world evidence • Clinical • Real-world
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    1year
    The real-world data of the cancer genome profiling testing for pancreatic ductal adenocarcinoma from a nationwide database in Japan (AACR 2023)
    Detection rates of gene alteration vary widely between tissue and liquid samples. KRAS mutation is confirmed as a poor prognostic factor for PDAC and patients with BRCA1/2 mutation are sensitive to FOLFIRINOX. Further accumulation of cases will help us to elucidate the more details of the relationship between gene alteration and therapeutic efficacy.
    Real-world evidence • Clinical • BRCA Biomarker • Real-world
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ARID1A (AT-rich interaction domain 1A) • PALB2 (Partner and localizer of BRCA2) • SMAD4 (SMAD family member 4)
    |
    TP53 mutation • KRAS mutation • BRCA2 mutation • BRCA1 mutation • HRD
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    |
    5-fluorouracil • irinotecan • leucovorin calcium
    over1year
    Malignant testicular unclassified sex cord stromal tumor: a case report. (PubMed, J Med Case Rep)
    We encountered a case of malignant testicular unclassified sex cord stromal tumor pathologically diagnosed as testicular tumor with retroperitoneal lymph node metastasis in a patient who underwent inguinal orchiectomy. Future data collection is necessary to establish multimodality therapy for malignant testicular unclassified sex cord stromal tumor.
    Journal
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8) • AFP (Alpha-fetoprotein) • NKX2-1 (NK2 Homeobox 1) • GATA3 (GATA binding protein 3) • PAX8 (Paired box 8)
    |
    OncoGuide™ NCC Oncopanel System
    |
    cisplatin • etoposide IV
    over1year
    Current Clinical Practice of Precision Medicine Using Comprehensive Genomic Profiling Tests in Biliary Tract Cancer in Japan. (PubMed, Curr Oncol)
    In Japan, matched therapies for four markers (NTRK, MSI-H, TMB-H, and FGFR2) are reimbursed by public insurance (as of September 2022). The progress of genomic profiling technology will contribute to the improvement of the dismal clinical outcomes of this disease in the future.
    Review • Journal • MSi-H Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • RET (Ret Proto-Oncogene) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF V600E • TMB-H • MSI-H/dMMR • HER-2 overexpression • BRAF V600 • HER-2 mutation • IDH1 mutation • RET fusion • FGFR2 mutation • FGFR2 fusion • RET mutation • RET rearrangement • NTRK fusion
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    over1year
    Proportion of unresectable pancreatic cancer specimens obtained by endoscopic ultrasound-guided tissue acquisition meeting the OncoGuide™ NCC Oncopanel System analysis suitability criteria: a single-arm, phase II clinical trial. (PubMed, J Gastroenterol)
    The proportion of patients with UR-PC who met the NOP analysis suitability criteria for EUS-TA using a 19G FNB needle was effective for achieving the primary endpoint, making it a valid test method. Adverse events occurred at a higher rate than that previously reported.
    Journal • P2 data
    |
    OncoGuide™ NCC Oncopanel System
    over1year
    Sysmex applies for a partial change for the OncoGuide™ NCC Oncopanel System as a companion diagnostic for the treatment of advanced biliary tract cancer (Sysmex Press Release)
    "Sysmex Corporation...applied on September 2, 2022 for a partial change of the manufacturing and marketing approval for the OncoGuide™ NCC Oncopanel System, a gene mutation analysis set (the 'System') to include its use as a companion diagnostic for patients with advanced biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions."
    Clinical
    |
    OncoGuide™ NCC Oncopanel System
    over1year
    Fine-needle biopsies with 19-gauge needle are effective combination modalities of EUS-tissue acquisition for genomic profiling of unresectable pancreatic cancer. (PubMed, Dig Endosc)
    In sample collection via EUS-TA, 19-gauge and FNB needles contribute to NOP analysis suitability.
    Journal
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    2years
    Druggable gene alterations in Japanese patients with rare malignancy (AACR 2022)
    In this study, the ratio of rare malignancy was higher than that typically found in previous epidemiological studies (about 20%-25%). We observed no adverse impact for OS, which might be due to the high number of patients (n=48) with intractable pancreatic cancer. Remarkably, >20% of patients harbored a potential druggable alteration.
    Clinical • Tumor mutational burden • MSi-H Biomarker • BRCA Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • 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) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • ARID1A (AT-rich interaction domain 1A) • EWSR1 (EWS RNA Binding Protein 1)
    |
    TP53 mutation • BRAF V600E • KRAS mutation • TMB-H • MSI-H/dMMR • HER-2 amplification • PIK3CA mutation • BRAF V600 • ARID1A mutation • FGFR2 fusion • PIK3CA E542K • PIK3CA E542
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    over2years
    Study protocol for NCCH1908 (UPFRONT-trial): a prospective clinical trial to evaluate the feasibility and utility of comprehensive genomic profiling prior to the initial systemic treatment in advanced solid tumour patients. (PubMed, Jpn J Clin Oncol)
    This study, initiated in June 2020, has been registered in the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) (registration number: UMIN000040743). We plan to enrol a total of 200 patients over a period of 21 months.
    Journal • Clinical
    |
    OncoGuide™ NCC Oncopanel System
    over2years
    Current Status of Next-Generation Sequencing-Based Cancer Genome Profiling Tests in Japan and Prospects for Liquid Biopsy. (PubMed, Life (Basel))
    "Measuring the drug access rate is not enough due to patients' deteriorating condition during CGP analysis and due to the limited number of ongoing clinical trials available, although tumor-agnostic therapies, such as the use of pembrolizumab in high microsatellite-instable solid tumors and in conditions with a high tumor mutational burden (≥10 mut/Mb) as well as the use of entrectinib and larotrectinib in NTRK fusion-positive tumors have been approved in Japan. However, cost, timing, and the number of tests allowed by the health system have not yet been determined. Therefore, in this review, we outline the current status and issues of CGP testing using tumor tissues as well as the expectations and limitations of liquid biopsy for use in Japanese clinical practice."
    Journal • Liquid biopsy
    |
    TMB (Tumor Mutational Burden) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    TMB-H • NTRK positive • NTRK fusion
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System • OncoPanel™ Assay
    |
    Keytruda (pembrolizumab) • Vitrakvi (larotrectinib) • Rozlytrek (entrectinib)