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    TEST:
    VENTANA® TROP2 (EPR20043) RxDx Assay

    Company:
    Roche
    Type:
    Laboratory Developed Test
    Related tests:
    Details
    Evidence

    News

    7d
    ALINEAR: Trop2 NMR Concordance Study (clinicaltrials.gov)
    P=N/A, N=3400, Not yet recruiting, AstraZeneca
    New trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • 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)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • EGFR L861Q • ROS1 rearrangement • EGFR G719X • EGFR S768I
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    VENTANA® TROP2 (EPR20043) RxDx Assay
    1year
    Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer (Roche Press Release)
    "The VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment; The device uses artificial intelligence-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods; This Breakthrough Device Designation (BDD) demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology."
    FDA event
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    VENTANA® TROP2 (EPR20043) RxDx Assay