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    TEST:
    OncoGuide™ NCC Oncopanel System

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    Evidence

    News

    6d
    Genomic Analysis of Advanced Phyllodes Tumors Using Next-Generation Sequencing and Their Chemotherapy Response: A Retrospective Study Using the C-CAT Database. (PubMed, Medicina (Kaunas))
    One patient with a high tumor mutational burden (37/Mb) responded to pembrolizumab... Our findings suggest distinct molecular patterns in phyllodes tumors compared to other soft tissue sarcomas, with potential implications for treatment selection. The identification of specific genetic alterations associated with treatment resistance may guide therapeutic decision-making, while the presence of actionable mutations in select cases indicates potential opportunities for targeted therapy approaches.
    Retrospective data • Journal • Next-generation sequencing • Tumor mutational burden • PD(L)-1 Biomarker • Metastases
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    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MSH6 (MutS homolog 6) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B)
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    TP53 mutation • TMB-H
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    |
    Keytruda (pembrolizumab)
    12d
    Association between homologous recombination deficiency and time to treatment failure to platinum-based chemotherapy for pancreatic cancer by using the C-CAT database. (PubMed, J Gastroenterol)
    Our findings suggest that HRR-related genetic abnormalities might be predictive of TTF in platinum-based chemotherapy for PC.
    Journal • BRCA Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • BARD1 (BRCA1 Associated RING Domain 1)
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    HRD • CDK12 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • BARD1 mutation
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • irinotecan • leucovorin calcium
    13d
    Analysis of cancer multigene panel testing for osteosarcoma in pediatric and adults using the center for cancer genomics and advanced therapeutics database in Japan. (PubMed)
    "Precision medicine for rare tumors still poses challenges. In this Japanese cohort, 42.2 % of high-grade OSs had potentially actionable alterations per CKDB. Concurrent gene amplifications of KIT, KDR, and PDGFRA at 4q12, and VEGFA and CCND3 at 6p12-21, might offer promising therapeutic options for patients with recurrent/metastatic OS resistant to conventional chemotherapy."
    Journal
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    FoundationOne® CDx • FoundationOne® Liquid CDx • MSK-IMPACT • OncoGuide™ NCC Oncopanel System
    26d
    Current status of cancer genomic profiling (CGP) tests in brain tumor treatment - complementing brain tumor pathological diagnosis with CGP- (SNO 2024)
    Molecular diagnostics through CGP testing served as an aid in diagnosis according to WHO2021. Cases where drug suggestions were feasible underwent treatment with targeted molecular therapies and checkpoint inhibitor. We experienced cases where hereditary cancer syndromes such as Lynch syndrome were diagnosed through the detection of germline pathogenic variants.
    BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • MSH6 (MutS homolog 6)
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    BRAF V600E • TMB-H • BRAF V600 • IDH1 R132H • TERT mutation • IDH wild-type • IDH1 R132 • IDH mutation + BRAF V600E
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    1m
    Development of a method for detecting genetic mutations in early breast cancer using Plasma-Safe-SeqS technology and its clinical application. (SABCS 2024)
    In addition to the postoperative blood sampling described above, we are currently conducting (1) postoperative blood sampling and (2) postoperative blood sampling after completion of adjuvant therapy. We aim to ascertain whether this mutation can serve as a predictive marker for response to postoperative chemotherapy or recurrence, especially in hormone-positive breast cancer patients at high risk of recurrence.
    Clinical
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
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    TP53 mutation • HER-2 negative • PIK3CA mutation • AKT1 mutation
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    OncoGuide™ NCC Oncopanel System
    1m
    Mapping the Genomic Landscape: Comprehensive Profiling of Diverse Histological Types of Breast Cancer (SABCS 2024)
    Despite the limited number of cases in some histological types, this study revealed genomic characterizations among many histological types of BC. This information will provide an important basis for considering genome-based precision medicine in the future.
    Tumor mutational burden • BRCA Biomarker • MSi-H Biomarker
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    ER (Estrogen receptor) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • NTRK (Neurotrophic receptor tyrosine kinase)
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    BRCA2 mutation • TMB-H • MSI-H/dMMR • NTRK fusion
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    2ms
    Leveraging non-coding regions to guarantee the accuracy of small-sized panel-based tumor mutational burden estimates. (PubMed, Cancer Sci)
    Additionally, the mean difference in TMB values compared with WES was lower for NOP-overall (3.55 [95% CI: 0.98-6.13]) than for NOP-coding (6.22 [95% CI: 3.73-8.70]). These results exemplify the utility of incorporating non-coding regions to maintain accurate TMB estimates in small-sized panels.
    Journal • Tumor mutational burden • IO biomarker
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    TMB (Tumor Mutational Burden)
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    3ms
    Analysis of cancer multigene panel testing for osteosarcoma using the Center for Cancer Genomics and Advanced Therapeutics database in Japan (ESMO Asia 2024)
    In this Japanese cohort, 42.2% of high-grade OSs had potentially actionable alterations per CKDB. Concurrent gene amplifications of KIT , KDR , and PDGFRA at 4q12, and VEGFA and CCND3 at 6p12-21, might offer promising therapeutic options for patients with recurrent/metastatic OS resistant to conventional chemotherapy.
    Metastases
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    FoundationOne® CDx • MSK-IMPACT • OncoGuide™ NCC Oncopanel System
    3ms
    Utility of Transpapillary Biopsy and Endoscopic Ultrasound-Guided Tissue Acquisition for Comprehensive Genome Profiling of Unresectable Biliary Tract Cancer. (PubMed, Cancers (Basel))
    In TPB, papillary-type lesions (66.7% vs. 3.2%, p = 0.016) and peroral cholangioscopy-assisted biopsies (50.0% vs. 3.3%, p = 0.029) showed better potential for successful NCCOP analysis. EUS-TA is suitable for NCCOP analysis in UR-BTC and may be partially complemented by TPB.
    Journal • Biopsy
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    3ms
    Study Protocol for a Prospective Self-Controlled Trial on Success in Meeting Comprehensive Genomic Profiling Analysis Criteria for Specimens Obtained by Endoscopic Ultrasound-Guided Tissue Acquisition Using a 19G Needle from Primary and Metastatic Lesions in Pancreatic Cancer with Metastatic Lesions: The PRIMATE Study. (PubMed, Diseases)
    The results of this study will be reported at an international conference and published in an international peer-reviewed journal. The trial registration number is UMIN 000048966.
    Journal • Metastases
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    OncoGuide™ NCC Oncopanel System
    4ms
    Lymphadenopathy Tissue Sampling by EUS-Guided Fine-Needle Biopsy Contributes to Meeting the Conditions for Genomic Profiling. (PubMed, J Clin Gastroenterol)
    EUS-FNB performed using Franseen or Fork-tip needles may result in greater lymphadenopathy tissue acquisition and thus enhanced suitability for genomic profiling compared with EUS-FNA.
    Journal • Biopsy
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    5ms
    Larotrectinib efficacy for liver metastases in papillary thyroid carcinoma patient harboring SQSTM1-NTRK1 fusion. (PubMed, Surg Case Rep)
    In conclusion, larotrectinib demonstrated effective antitumor activity against liver metastases of PTC, a relatively rare site of distant metastasis. Furthermore, the efficacy of larotrectinib was maintained, even though the patient had a history of multi-tyrosine kinase inhibitor treatment and a relatively infrequent fusion gene, SQSTM1-NTRK1.
    Journal
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    NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • SQSTM1 (Sequestosome 1) • NTRK (Neurotrophic receptor tyrosine kinase)
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    OncoGuide™ NCC Oncopanel System
    |
    Vitrakvi (larotrectinib) • Lenvima (lenvatinib)
    5ms
    Three cases of malignant phyllodes tumor in our department (JBCS 2024)
    Eribulin and pazopanib were administered, but the treatment was ineffective and the patient passed away...The patient requested conservative observation with only denosumab administration, and subsequently passed away...These two mutations were consistent with Cowden syndrome and Li-Fraumeni syndrome, but there was no family history, so the patient was diagnosed with a somatic mutation. We report the progress of the cases and the genetic mutations, including a literature review
    Clinical • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • NF1 (Neurofibromin 1) • TERT (Telomerase Reverse Transcriptase) • KMT2D (Lysine Methyltransferase 2D)
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    |
    pazopanib • Halaven (eribulin mesylate) • Prolia (denosumab)
    5ms
    Current status and issues of cancer genomic medicine from the viewpoint of cancer genomic medicine affiliated hospitals (JBCS 2024)
    [Future Issues] Although we have established a Cancer Genomic Medical Center and aim to centralize the workflow, we are not blessed with as many specialized personnel as the core hospitals. In the future, as the number of CGP tests increases, reducing the burden of sending out tests and entering information into C-CAT is considered to be one of the important issues for affiliated hospitals
    Clinical
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    FoundationOne® CDx • Guardant360® CDx • OncoGuide™ NCC Oncopanel System
    5ms
    Study of cancer gene panel testing at our hospital (JBCS 2024)
    [Discussion] There are reports that performing CGP testing may increase treatment options, such as cases where TMB-high was found even in luminal type and HER2 type, and cases where companion testing for the BRCA gene showed VUS were proposed for treatment with olaparib by the expert panel...In addition, 2 cases were proposed to participate in clinical trials, but they did not want to do so because the facilities where clinical trials are available are far away and it is difficult to visit the hospital. In the future, it is considered that efforts will be needed to share information and participate in clinical trials to bridge regional disparities
    Clinical • PARP Biomarker • BRCA Biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • FGFR (Fibroblast Growth Factor Receptor) • BRCA (Breast cancer early onset)
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    |
    Lynparza (olaparib)
    5ms
    Current status and challenges of comprehensive genomic profiling (CGP) testing for metastatic breast cancer (JBCS 2024)
    In this study, there were differences in the timing of CGP testing proposals (number of previous treatments) and treatment achievement rate depending on the subtype. Further ingenuity is needed in the future to propose CGP testing at the appropriate time for all metastatic recurrent cases and to increase the treatment achievement rate of recommended treatment based on the results of CGP testing
    Metastases
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    HER-2 (Human epidermal growth factor receptor 2)
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    FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    5ms
    Current status of gene panel testing in our department (JBCS 2024)
    In addition, we have experienced cases in which the patient was thought to be resistant to endocrine therapy in a hormone receptor-positive case, but had AKT1 and MTOR gene mutations, and was administered EVE+EXE, resulting in long-term stable disease, and cases in which the patient had high TMB and was administered pembrolizumab, resulting in a remarkable response...In addition, the timing of testing is basically when standard treatment is expected to end, but there are cases where the side effects of standard treatment are unacceptable due to age or comorbidities, or the disease progresses quickly and there is no time to spare. The timing of testing needs to be considered depending on each individual case, but we would like to proactively conduct testing when possible, in order to bring benefits to many patients
    Tumor mutational burden • PD(L)-1 Biomarker • PD(L)-1 companion diagnostic
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    TMB (Tumor Mutational Burden) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • mTOR (Mechanistic target of rapamycin kinase)
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    |
    Keytruda (pembrolizumab)
    5ms
    A study on the awareness of the financial burden of genetic testing in breast cancer treatment (JBCS 2024)
    Conclusion In a survey of breast cancer patients who underwent genetic testing, more than half of the cases felt it was a financial burden, similar to previous reports of patients with solid cancers who underwent chemotherapy. Further economic and toxicity evaluations that take into account different background factors are needed
    BRACAnalysis CDx™ • OncoGuide™ NCC Oncopanel System • Oncotype DX Breast Recurrence Score®Test
    5ms
    Treatment of secondary findings from cancer gene panel testing at a core hospital for cancer genomic medicine (JBCS 2024)
    Conclusion PGV/PGPV was detected in 8% of cases where CGP testing was performed, and more than half were genes related to hereditary breast cancer. Information could be provided at the genetic counseling session in 91% of cases, and a definitive diagnosis of hereditary tumors was made in 40% of cases, but there were few cases in which information was provided to blood relatives, suggesting that the examination of secondary findings at the end of treatment is a heavy burden for patients and their families
    Clinical • BRCA Biomarker
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    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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    FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    5ms
    The significance of breast cancer genomic profiling from the perspective of tumor mutation burden (TMB) and its therapeutic application (JBCS 2024)
    Only 13.5% of TMB-High cases reached pembrolizumab, making it clear that they were not able to reach treatment. It is necessary to promote the effective use of cancer genome profiles by conducting testing as early as possible and improving companion functions
    Tumor mutational burden • PD(L)-1 Biomarker • BRCA Biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • 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) • ARID1A (AT-rich interaction domain 1A) • DDR2 (Discoidin domain receptor 2)
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
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    Keytruda (pembrolizumab)
    7ms
    Real-world data in Japan for the variants in homologous recombination gene on the etiology of gastric cancer in younger and older patients. (ASCO 2024)
    In the present study, the YGC group had lower incidence of variants in HR gene and MSI-H, and lower value of TMB, compared with those in the EGC group. We estimate that the incidence of MSI-H and the value of TMB caused by the HR-deficiency, which may be linked with prognosis, differs according to the frequencies of the variants in HR gene or according to other factors, such as aging and lifestyle.
    Real-world evidence • Clinical • Tumor mutational burden • MSi-H Biomarker • BRCA Biomarker • Real-world
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    TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog) • ATM (ATM serine/threonine kinase) • ARID1A (AT-rich interaction domain 1A) • BAP1 (BRCA1 Associated Protein 1) • PALB2 (Partner and localizer of BRCA2) • CDK12 (Cyclin dependent kinase 12) • ATRX (ATRX Chromatin Remodeler) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • BARD1 (BRCA1 Associated RING Domain 1) • MRE11A (MRE11 homolog, double strand break repair nuclease) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • FANCC (FA Complementation Group C)
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    9ms
    ASSOCIATION OF CANCER GENE PROFILE TEST FOR BILIARY TRACT CANCER WITH CLINICOPATHOLOGICAL FEATURES. (DDW 2024)
    9%) and ld-ICC 0% (0/6) of which 3 patients were treated (Pemigatinib for cases clinical trial for 1case). A: The success rate of CGP (tissue) examination was 100% ( 1/ 1) for resection specimens 100% (9/9) for liver biopsy and 3/7 (4 . 9%) for biopsy. B: The median TMB was 3 (IQR 1-4) and the median number of variants detected was 4 (IQR .
    Clinical • MSi-H Biomarker
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    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • FGFR1 (Fibroblast growth factor receptor 1) • BAP1 (BRCA1 Associated Protein 1)
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    MSI-H/dMMR • FGFR2 fusion • FGFR1 fusion
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
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    Pemazyre (pemigatinib)
    9ms
    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
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    9ms
    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)
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    BRAF mutation • BARD1 mutation
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    |
    Braftovi (encorafenib)
    9ms
    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
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    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)
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    9ms
    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)
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    11ms
    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
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    BRCA2 (Breast cancer 2, early onset)
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    BRCA2 mutation
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    12ms
    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)
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    BRAF V600E • KRAS mutation • BRCA2 mutation • TMB-H • MSI-H/dMMR • HER-2 amplification • BRAF V600 • KRAS G12D • KRAS G12 • BRAF amplification
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    12ms
    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)
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    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
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    1year
    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
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    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)
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    TMB-H • MSI-H/dMMR • NTRK1 fusion • NTRK3 fusion • ALK fusion • ROS1 fusion • NTRK fusion
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    1year
    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)
    1year
    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
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    OncoGuide™ NCC Oncopanel System
    over1year
    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
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    OncoGuide™ NCC Oncopanel System
    |
    Lytgobi (futibatinib)
    over1year
    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
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    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)
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    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
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
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    Keytruda (pembrolizumab) • Vitrakvi (larotrectinib) • Rozlytrek (entrectinib) • imatinib
    over1year
    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
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    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • PTEN (Phosphatase and tensin homolog)
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    TMB-H • PIK3CA mutation • PTEN mutation • PIK3CA mutation + PTEN mutation
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    over1year
    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
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    TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • CDK4 (Cyclin-dependent kinase 4)
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    OncoGuide™ NCC Oncopanel System
    over1year
    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
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency)
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    BRCA2 mutation • BRCA1 mutation • HRD • ATM mutation • HRD + BRCA1 mutation • BRCA1 mutation + BRCA2 mutation
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    Myriad myChoice® CDx Plus • OncoGuide™ NCC Oncopanel System
    over1year
    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
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    FoundationOne® CDx • FoundationOne® Liquid CDx • TruSight Oncology 500 Assay • OncoGuide™ NCC Oncopanel System
    over1year
    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
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    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • FBXW7 (F-Box And WD Repeat Domain Containing 7)
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    OncoGuide™ NCC Oncopanel System
    over1year
    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
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    over1year
    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
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    over1year
    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
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    FoundationOne® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System