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    How the ALK FISH diagnostic works to identify patients who may benefit from ALK-directed therapy  

    The ALK gene rearrangements define a novel subclass of NSCLC1-3:

    • Involve a gene fusion between ALK and the promoter region of another gene1
    • ALK can partner with several genes including EML4, TFG, and KIF5B1,4
    • Breakpoints in EML4 can vary, while the breakpoint in ALK is consistent1,4,5

    Vysis ALK dual color, break apart rearrangement probes:

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    Early FISH testing at diagnosis can assist physicians in determining appropriate ALK-directed therapy
    Vysis ALK is a FISH-based test that is intended for all NSCLC tissue specimens, including not otherwise specified (NOS) specimens.

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    Sample Type for Vysis ALK

    Lung cancer tissue specimens fixed in formalin are required for the Vysis ALK Test.

    • The specimen should be obtained by a surgeon, ideally under the supervision of the pathologist.
    • Sufficient specimen should be obtained during a single surgical procedure for the range of tests that the pathologist may order.

    To Order Lung Cancer Tests
    For Specimen Collection and Shipping Instructions

    References

    1. 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

    2. Horn L, Pao W. EML4-ALK: honing in on a new target in non-small-cell lung cancer. J Clin Oncol. 2009;27:4232-4235

    3. Shaw AT, Yeap BY, Mino-Kenudson M, et al. Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J 
    Clin Oncol. 2009;27:4247-4253

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

    5. 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

     

    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

    • FOR IN VITRO DIAGNOSTIC USE ONLY.
    • 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.

    Caution

    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.

    FOR IN VITRO DIAGNOSTIC USE ONLY