The ALK gene provides instructions for making a protein called ALK, part of a family of proteins called receptor tyrosine kinases (RTKs). FISH provides researchers with a way to visualize and map the genetic material in an individual's cells, including specific genes or portions of genes.
The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via FISH in formalin-fixed paraffin-embedded (FFPE) NSCLC tissue specimens to aid in identifying those patients eligible for treatment with crizotinib (Xalkori®). Fluorescence in situ hybridization technology is used to detect chromosome 2p23 rearrangements. Rearrangement of the ALK locus on 2p23 has been implicated in the development of NSCLC.
ALK gene by FISH testing with the Vysis ALK Break Apart FISH Probe Kit may be considered medically necessary for individuals with advanced or metastatic NSCLC who are considering crizotinib (Xalkori) for the treatment.
All other uses of the Vysis ALK Break Apart FISH Probe Kit testing are considered experimental/investigational and therefore, non-covered. The safety and/or effectiveness cannot be established by review of the published peer-reviewed literature.
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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
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