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    TEST:
    VENTANA ALK (D5F3) CDx Assay

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    1m
    A Multicenter, Open-label, Randomized Phase III Clinical Trial: Evaluating the Efficacy and Safety of SAF-189s Assisted Therapy Compared to Platinum-based Chemotherapy in Fully Resected Patients with Stage II to IIIB ALK-positive or ROS1-positive NSCLC (ChiCTR2500109405)
    P3, N=210, Not yet recruiting, Shanghai Oriental Hospital; Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.
    New P3 trial
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    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    ALK positive • ROS1 positive
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    VENTANA ALK (D5F3) CDx Assay
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    cisplatin • pemetrexed • foritinib (SAF-189)
    1m
    A real-world study on the progression patterns and coping strategies of second-generation ALK TKI in the treatment of NSCLC (ChiCTR2500108970)
    P4, N=300, Not yet recruiting, The Fourth Hospital of Hebei Medical tniversity Hebei Tuor Hospital; The Fourth Hospital of Hebei Medical tniversity Hebei Tuor Hospital
    New P4 trial • Real-world evidence
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    ALK (Anaplastic lymphoma kinase)
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    ALK positive • ALK mutation
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    VENTANA ALK (D5F3) CDx Assay
    6ms
    Case Report: ALK-rearranged mesenchymal neoplasms with S100 and CD34 co-expression: additional cases with distinct characteristics. (PubMed, Front Oncol)
    In case 1, no indications of disease progression or metastasis was observed within the limited follow-up (36 months). However, the patient in case 2 experienced a rapid recurrence and metastasis.
    Journal
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    ALK (Anaplastic lymphoma kinase) • STRN (Striatin) • CD34 (CD34 molecule) • NTRK (Neurotrophic receptor tyrosine kinase) • PLEKHH2 (Pleckstrin Homology, MyTH4 And FERM Domain Containing H2)
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    ALK rearrangement • ALK fusion
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    VENTANA ALK (D5F3) CDx Assay
    6ms
    High concordance between Immunohistochemistry and RT-PCR in diagnosing ALK rearrangement in lung adenocarcinoma cytologic samples. (PubMed, Med J Malaysia)
    The high concordance between IHC and qRTPCR underscores their reliability in detecting ALK rearrangements, crucial for the precise diagnosis and treatment of lung adenocarcinoma in Indonesia. These findings support the use of either method, depending on available resources and expertise, to enhance lung cancer management.
    Observational data • Journal
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    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4)
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    EGFR mutation • ALK rearrangement • ALK fusion
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    VENTANA ALK (D5F3) CDx Assay
    8ms
    CUBIK: Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Fundación GECP | Trial completion date: Apr 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Liquid biopsy
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    ALK (Anaplastic lymphoma kinase)
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    ALK positive • ALK rearrangement
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    VENTANA ALK (D5F3) CDx Assay
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    Alunbrig (brigatinib)
    8ms
    PD-L1 and ALK expressions in stages III and IV colorectal cancer and their correlation with clinicopathological features. (PubMed, Medicine (Baltimore))
    PD-L1 expression was associated with poor prognostic factors, including shorter survival. Further investigation is needed to understand the mechanisms of the association between PD-L1 expression and unfavorable CRC prognosis.
    Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
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    PD-L1 expression
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    VENTANA PD-L1 (SP263) Assay • VENTANA PD-L1 (SP142) Assay • VENTANA ALK (D5F3) CDx Assay
    10ms
    SMARCA4/BRG1-deficient non-small cell lung cancer: clinical, imaging, pathological features, and follow-up results of 23 patients. (PubMed, Transl Lung Cancer Res)
    FDG PET/CT is recommended when S/B-d NSCLC is suspected based on CT features, especially for large lesions. The FDG PET/CT scan can help with accurate staging and individual treatment planning.
    Journal
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    ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • KEAP1 (Kelch Like ECH Associated Protein 1) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • CEACAM5 (CEA Cell Adhesion Molecule 5) • MUC16 (Mucin 16, Cell Surface Associated) • TP63 (Tumor protein 63)
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    VENTANA ALK (D5F3) CDx Assay
    11ms
    Alectinib treatment for 2 non-small cell lung carcinoma patients carrying different novel ALK fusions. (PubMed, Zhong Nan Da Xue Xue Bao Yi Xue Ban)
    It offered compelling evidences that the individuals with NSCLC and harboring either a PNPT1-ALK (Exon22:Exon20) fusion or a TCEAL2-ALK (Exon3:Exon19) fusion, experience favorable therapeutic outcomes through the administration of alectinib. This study expands the known ALK fusion variants database and supports the precision treatment of NSCLC using ALK tyrosine kinase inhibitors (TKIs).
    Journal
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    ALK (Anaplastic lymphoma kinase) • NKX2-1 (NK2 Homeobox 1)
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    ALK fusion
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    VENTANA ALK (D5F3) CDx Assay
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    Alecensa (alectinib)
    1year
    A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China (clinicaltrials.gov)
    P2; Active, not recruiting --> Completed
    Trial completion • Metastases
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    EML4 (EMAP Like 4)
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    ALK positive • EML4-ALK fusion • ALK fusion
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    VENTANA ALK (D5F3) CDx Assay • Vysis ALK Break Apart FISH Probe Kit • AmoyDx® EML4-ALK Fusion Gene Detection Kit
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    Lorbrena (lorlatinib)
    1year
    ALK Immunohistochemistry as the Initial Screening Method of a Reflex Testing Approach for the Detection of ALK Gene Rearrangements in Non-Small-Cell Lung Cancers (AMP 2024)
    Screening for ALK rearrangements with IHC is both reliable and cost effective. In-house testing with IHC removes reliance on send-out testing for ALK detection, effectively cutting costs and decreasing TAT. Additionally, the creation of a reflex algorithm can improve lung cancer biomarker testing processes within hospitals.
    PD(L)-1 Biomarker • IO biomarker • Reflex
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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    ALK positive • ALK rearrangement • ALK negative
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    VENTANA ALK (D5F3) CDx Assay • Idylla™ GeneFusion Assay
    1year
    Superficial ALK-Rearranged Myxoid Spindle Cell Neoplasm (SAMS) with Overlapping Features of Epithelioid Fibrous Histiocytoma (ASDP 2024)
    These findings further substantiate the hypothesis that SAMS and epithelioid FH may represent a morphologic and genetic spectrum. The differential diagnosis, clinical follow up, and the molecular genetic findings will be discussed.
    ALK (Anaplastic lymphoma kinase) • CD34 (CD34 molecule) • SOX10 (SRY-Box 10) • F13A1 (Coagulation Factor XIII A Chain)
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    ALK rearrangement
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    VENTANA ALK (D5F3) CDx Assay
    1year
    ALTA-3: A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer (clinicaltrials.gov)
    P3; Active, not recruiting --> Completed
    Trial completion
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    ALK (Anaplastic lymphoma kinase)
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    ALK positive • ALK rearrangement
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    FoundationOne® CDx • VENTANA ALK (D5F3) CDx Assay
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    Xalkori (crizotinib) • Alecensa (alectinib) • Alunbrig (brigatinib)