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    ALK Break Apart FISH Probe Kit (Vysis ALK)

    The FDA-approved Vysis ALK is a FISH-based (fluorescence in situ hybridization) test that identifies ALK gene rearrangements in non-small cell lung cancer (NSCLC) patients. Vysis ALK is the only FDA-approved ALK companion diagnostic validated in XALKORI® (crizotinib) clinical trials.

    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 KIF5B1,7-14
    • Breakpoints in EML4 can vary, while the breakpoint in ALK is consistent1,4,5

    The National Comprehensive Cancer Network (NCCN Guidelines™) recognizes FISH as a specifically designed method for identifying ALK-rearranged adenocarcinomas.6

    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

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

    7. Choi YL, et al. Identification of novel isoforms of the EML4-ALK transforming gene in non-small cell lung cancer. Cancer Res. 2008;68:4971-6

    8. Takeuchi K, et al. Multiplex reverse transcription-PCR screening for EML4-ALK fusion transcripts. Clin Cancer Res. 2008;14:6618-24

    9. Koivunen JP, et al. EML4-ALK fusion gene and efficacy of an ALK kinase inhibitor in lung cancer. Clin Cancer Res. 2008;14:4275-83

    10. Wong D, et al. The EML4-ALK fusion gene is involved in various histologic types of lung cancers from nonsmokers with wildtype EGFR and KRAS. Cancer. 2009; April 15:1723-33

    11. Sanders HR, et al. Exon scanning by reverse transcriptaseepolymerase chain reaction for detection of known and novel EML4eALK fusion variants in non-small cell lung cancer. Can Gen. 2011;204:45-53

    12. Takeuchi K, et al. KIF5B-ALK, a novel fusion oncokinase identified by an immunohistochemistry-based diagnostic system for ALK-positive lung cancer. Clin Can Res. 2009;15:3143-49

    13. Wong D, et al. A novel KIF5B-ALK variant in nonsmall cell lung cancer. Cancer. 2011;117:2709-18

    14. Rikova K, et al. Global survey of phosphotyrosine signaling identifies oncogenic kinases in lung cancer. Cell, 2007;131:1190-203

    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