Vysis ALK Break Apart FISH Probe Kit

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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)

Warnings and Limitations

  1. 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 only on 10% neutral buffered FFPE human lung tumor tissue. Other types of specimens or fixatives should not be used.
  2. 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.
  3. 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.
  4. FISH assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate.
  5. Technologists performing the FISH signal enumeration must be capable of visually distinguishing between the orange, green and yellow signals.

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When hybridized with the LSI ALK Dual Color, Break Apart Rearrangement Probe, the 2p23 ALK region in its native state will be seen as two immediately adjacent or fused orange/green (yellow) signals (2F). However, if a t(2;5) or other chromosome rearrangement at the 2p23 ALK breakpoint region has occurred, one orange and one green signal will be seen, while the native ALK region will remain as an orange/ green fusion signal (1O1G1F). The hybridization result of the LSI ALK Dual Color, Break Apart Rearrangement Probe containing the t(2;5) translocation will be the centromeric green probe remaining at 2p23, while the telomeric orange signal that covers the region is translocated to 5q35 on the derivative chromosome.

Abnormal Hybridization: Hybridization image demonstrating a break in the ALK locus. Vysis ALK Break abnormal (positive) signal pattern is represented by 1 green, 1 red and 1 fusion signal.