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    TEST:
    INFORM HER2 Dual ISH DNA Probe Cocktail

    Company:
    Roche
    Type:
    FDA Approved
    Related tests:
    6ms
    Dual HER2 Testing With Both Immunohistochemistry (IHC) and ISH (In Situ Hybridization): Long Term Analysis of Dual Testing in a Single Academic Institution. (SABCS 2023)
    In this large single institutional analysis of dual HER-2 testing, only 12% of cases demonstrate HER-2 amplification, and overall in our institutional pathology database, from 2001 – March 2023, 11.2% of cases are HER-2+ by either IHC or ISH. In our dual tested cohort, only 13.6% of IHC 2+ cases demonstrate amplification, and 13.8% are non-amplified, but have excess HER-2 copy number. We demonstrate a numerical increase in the rate of amplification, and copy number in non-amplified cases, associated with IHC score.
    Clinical
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HercepTest • INFORM HER2 Dual ISH DNA Probe Cocktail • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    almost2years
    HER2 in uterine carcinosarcoma: Testing platforms and implications for targeted therapy. (ASCO 2022)
    Increased HER2 positivity was detected via CISH testing compared to IHC and NGS, which may reflect the heterogeneity of HER2 amplification due to mixed histology between the sarcoma and carcinoma portion of the tumor. High concordance rates were observed between CISH and IHC. These testing platforms need to be validated by response to HER2 targeted therapies in order to develop UCS specific testing guidelines.
    Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1)
    |
    PD-L1 expression • HER-2 positive • TP53 mutation • KRAS mutation • MSI-H/dMMR • HER-2 amplification • PIK3CA mutation • PTEN mutation • KRAS amplification • PIK3R1 mutation • HER-2 amplification + PD-L1 expression
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    VENTANA PD-L1 (SP142) Assay • INFORM HER2 Dual ISH DNA Probe Cocktail • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    almost3years
    [VIRTUAL] HER2 in uterine serous carcinoma: Testing platforms and implications for targeted therapy. (ASCO 2021)
    High concordance rates were observed between CISH and IHC . Ultimately these testing platforms need to be validated by response to HER2 targeted therapies in order to develop USC specific HER2 testing guidelines.
    Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog)
    |
    PD-L1 expression • HER-2 positive • TMB-H • MSI-H/dMMR • HER-2 mutation
    |
    VENTANA PD-L1 (SP142) Assay • INFORM HER2 Dual ISH DNA Probe Cocktail • PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody • MI Tumor Seek™
    3years
    Molecular and pathological analyses of gastric stump cancer by next-generation sequencing and immunohistochemistry. (PubMed, Sci Rep)
    "A high frequency of PD-L1 expression in TIICs and a high EBV infection rate suggest immune checkpoint inhibitors for treatment of GSC despite a relatively low frequency of deficient MMR gene expression. Other molecular characteristics such as PTEN and SMAD4 mutations might be considered to develop new treatment strategies."
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • SMAD4 (SMAD family member 4)
    |
    PD-L1 expression • TP53 mutation • PTEN mutation • SMAD4 mutation
    |
    INFORM HER2 Dual ISH DNA Probe Cocktail
    over3years
    Rapid HER2 cytologic fluorescence in situ hybridization for breast cancer using noncontact alternating current electric field mixing. (PubMed, Cancer Med)
    "CytoFISH could potentially serve as a clinical tool for prompt determination of HER2 status in breast cancer cytology. Rapid-CytoFISH with AC mixing will enable cancer diagnoses and HER2 status to be determined on the same day a patient comes to a clinic or hospital."
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    INFORM HER2 Dual ISH DNA Probe Cocktail