Intended User

The intended users for the Vysis ALK Break Apart FISH Probe Kit are laboratory professionals.

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 package insert.
• 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 tumor 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 package insert only. Modifications to these 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.