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    VYSIS ALK BREAK APART FISH lets the patient’s signal guide the need for ALK-directed therapy 

    ALK test results provide a clear positive or negative result. The test identifies ALK gene rearrangements in NSCLC patients so that the oncologist can determine which patients can potentially benefit from the ALK-directed therapeutic drug XALKORI®.

    XALKORI® clinical trial information, Phase 21

    • 136 patients with locally advanced or metastatic ALK-positive NSCLC were treated with single-agent XALKORI® in a multi-center, single-arm study.
    • ALK-positive NSCLC was identified using the Vysis ALK Break Apart FISH Probe Kit.
    • Patients received 250 mg of XALKORI® orally twice daily.
    • Primary endpoint: Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
    • Median duration of treatment: 22 weeks.
    • Results: 1 complete and 67 partial responses for an ORR of 50% (95% CI: 42%, 59%). 79% of objective tumor responses were achieved during the first 8 weeks of treatment.

    Patients in this clinical trial were all ALK-positive and treated with XALKORI®, regardless of the phenotypic characteristics of sex, age, race, smoking status, or the histological classification of their NSCLC.


    Vysis ALK is the first molecular diagnostic test approved by the FDA to aid in identifying the ALK status of patients with NSCLC.



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

    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.