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    Vysis ALK Performance

    Vysis ALK, a FISH-based test, is the first molecular diagnostic test approved by the FDA to aid in identifying the ALK status of patients with NSCLC. The sensitivity and specificity of Vysis ALK have been analyzed, as shown in the FDA-approved labeling.1

    Why Order Vysis ALK? 

    Unlike IHC, which is highly subjective, and RT/PCR, which misses variants, the Vysis ALK test using break-apart FISH technology offers the benefits of: 

    • Identifying ALK gene rearrangements with fusion partners, including but not restricted to EML4, TFG, and KIF5B
    • Reducing false negative results, which provides confidence that patients are correctly identified and helps pathologists and oncologists to diagnose and appropriately manage their NSCLC patients 

    ALK Test Comparison


    To Order Lung Cancer Tests
    For Specimen Collection and Shipping Instructions


    1. Vysis ALK Break Apart FISH Probes Kit Package Insert 30-608495.

    2. Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007;448:561-567.

    3. Kwak EL, Bang Y-J, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010;363:1693-1703

    4.The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Non-Small Cell Lung Cancer (Version 1.2012). ©2011 National Comprehensive Cancer Network, Inc. Available at

    Intended Use

    The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib).
    The test is for prescription use only.

     Limitations of the Procedure

    • Optimal performance of this test requires appropriate specimen handling, preparation, and storage as described in the instructions for use.
    • The Vysis ALK Break Apart FISH Probe Kit has been optimized only for identifying and quantifying rearrangements of the ALK gene from formalin-fixed, paraffin-embedded human NSCLC tissue specimens. The assay should be performed only on 10% neutral buffered formalin FFPE human lung cancer tissue. Other types of specimens or fixatives should not be used.
    • The performance of the Vysis ALK Break Apart FISH Probe Kit was established using the procedures provided in the assay package insert only. Modifications to the procedures may alter the performance of the assay.
    • The clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic laboratory test results.
    • FISH assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate.
    • Technologists performing the FISH signal enumeration must be capable of visually distinguishing between the orange, green, and yellow signals.


    United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.

    XALKORI® is a registered trademark of Pfizer Inc.