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    over1year
    A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China (clinicaltrials.gov)
    P2; Trial completion date: Aug 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    EML4 (EMAP Like 4)
    |
    ALK positive • EML4-ALK fusion • ALK fusion
    |
    VENTANA ALK (D5F3) CDx Assay • Vysis ALK Break Apart FISH Probe Kit • AmoyDx® EML4-ALK Fusion Gene Detection Kit
    |
    Lorbrena (lorlatinib)
    over1year
    A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China (clinicaltrials.gov)
    P2; Trial completion date: Aug 2022 --> Aug 2023
    Trial completion date
    |
    EML4 (EMAP Like 4)
    |
    ALK positive • EML4-ALK fusion • ALK fusion
    |
    VENTANA ALK (D5F3) CDx Assay • Vysis ALK Break Apart FISH Probe Kit • AmoyDx® EML4-ALK Fusion Gene Detection Kit
    |
    Lorbrena (lorlatinib)
    over1year
    Is next generation sequencing the new golden standard for ALK testing? The diagnostic journey of an atypical case (ECP 2022)
    The unusual loss of the red signal suggested the presence of an atypical rearrangement in the 5' part of the ALK gene which required additional investigation. Using a NGS panel we identified an atypical EML4-ALK fusion which was not detected by break-apart conventional FISH. We highlight the need for a new gold standard for ALK rearrangements testing represented by RNA NGS, a more sensitive approach that could identify patients with rare molecular phenotypes and increase the addressability of targeted therapies.
    Clinical • Next-generation sequencing
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4)
    |
    ALK positive • ALK rearrangement • EML4-ALK fusion • ALK fusion • EGFR negative
    |
    Vysis ALK Break Apart FISH Probe Kit • Archer® FusionPlex® Lung Kit
    almost2years
    J-ALTA: Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2; Active, not recruiting --> Completed | Trial completion date: May 2022 --> Jul 2021
    Trial completion date • Trial completion
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK rearrangement
    |
    VENTANA ALK (D5F3) CDx Assay • Vysis ALK Break Apart FISH Probe Kit
    |
    Alunbrig (brigatinib)
    2years
    A novel fusion between CDC42BPB and ALK in a patient with quadruple wild-type gastrointestinal stromal tumor. (PubMed, Mol Genet Genomic Med)
    We unexpectedly found that this GIST patient showed ALK (D5F3) overexpression and harbored a novel fusion CDC42BPB exon 24-ALK in exon 20.
    Journal
    |
    ALK (Anaplastic lymphoma kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • CDC42BPB (CDC42 Binding Protein Kinase Beta)
    |
    KIT mutation • ALK fusion • PDGFRA mutation
    |
    VENTANA ALK (D5F3) CDx Assay • Vysis ALK Break Apart FISH Probe Kit
    |
    imatinib
    over2years
    Different Prevalence of Molecular Alterations for Non-Small Cell Lung Cancer in Mexican Cohort of 200 Patients (USCAP 2022)
    "Three differences of prevalence are observed in our study for mexican population with lung AC: EGFR 32.7%, 13.9% KRAS and ALK 6.7%. According to recent NGS studies in Mexico, EGFR has a prevalence of 36.7% and 20% for KRAS. In Mexico and Latin America (LA) the mutational frequency is inverse compared to Caucasian population, with KRAS (20-25%) being more frequent than EGFR (10-15%) and ALK (4.5-5%)."
    Clinical
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • KRAS mutation • EGFR mutation • ROS1 fusion • ALK-ROS1 fusion
    |
    VENTANA PD-L1 (SP263) Assay • therascreen® EGFR RGQ PCR Kit • therascreen® KRAS RGQ PCR Kit • Vysis ALK Break Apart FISH Probe Kit • Vysis ROS1 Break Apart FISH Probe Kit
    over2years
    Outcomes According to ALK Status Determined by Central IHC or FISH in Patients with ALK-Positive NSCLC Enrolled in the Phase III ALEX Study. (PubMed, J Thorac Oncol)
    Outcomes of patients with ALK IHC-positive/FISH-positive and ALK IHC-positive/FISH-uninformative NSCLC were similar to the overall ALEX population. These results suggest that Ventana ALK IHC is a standard testing method for selecting patients for treatment with alectinib.
    Journal • P3 data • Clinical
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK fusion
    |
    VENTANA ALK (D5F3) CDx Assay • Vysis ALK Break Apart FISH Probe Kit
    |
    Xalkori (crizotinib) • Alecensa (alectinib)
    over2years
    Detection of ALK Gene Rearrangements in Non-Small Cell Lung Cancer by Immunocytochemistry and Fluorescence in Situ Hybridization on Cytologic Samples. (PubMed, Turk Patoloji Derg)
    "Immunocytochemistry on cell- blocks using DF53 clone is a highly sensitive and specific method for the detection of ALK gene rearrangements in lung adenocarcinoma with a greater number of ALK positive cases being detected on ICC as compared to the ALK-FISH."
    Journal
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK rearrangement • ALK negative
    |
    Vysis ALK Break Apart FISH Probe Kit
    over3years
    Outcomes According to ALK Status Determined by Central Immunohistochemistry or Fluorescence In Situ Hybridization in Patients With ALK-Positive NSCLC Enrolled in the Phase 3 ALEX Study. (PubMed, J Thorac Oncol)
    Outcomes of patients with ALK IHC-positive and FISH-positive and ALK IHC-positive and FISH-uninformative NSCLC were similar to those of the overall ALEX population. These results suggest that Ventana ALK IHC is a standard testing method for selecting patients for treatment with alectinib.
    Journal • P3 data • Clinical
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK fusion
    |
    VENTANA ALK (D5F3) CDx Assay • Vysis ALK Break Apart FISH Probe Kit
    |
    Xalkori (crizotinib) • Alecensa (alectinib)
    over3years
    Application of FISH in the diagnosis of lung cancer (PubMed, Pathologe)
    "All other translocations, or discrepancy between IHC and FISH, require a sequencing-based confirmation procedure. The low frequency of NTRK fusions, and high sensitivity of NTRK-IHC, suggest using IHC as a prescreening tool with subsequent sequencing-based analysis for IHC positive cases."
    Journal • Review
    |
    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) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 expression • HER-2 amplification • ALK translocation • HER-2 amplification + PD-L1 expression • NTRK fusion
    |
    Vysis ALK Break Apart FISH Probe Kit