To Identify patients with late-stage, non-small cell lung cancers who may benefit from treatment with Xalkori (Crizotinib).
The ROS1 gene, a close evolutionary relative of ALK, encodes a receptor tyrosine kinase that activates some of the same signaling pathways as ALK. ROS1 rearrangements lead to constitutively active fusion proteins and are detected in 1% to 2% of NSCLC cases.
Collect 5 mm3 sample of involved tissue (solid tumor or other) and place in sterile culture medium, sterile Hanks Balance Salt Solution (HBSS) or sterile saline within 1 hr of procedure
Submit 2 unstained 5 micron cuts of involved tissue mounted on positively charged slides and 1 H & E
a formalin-fixed, paraffin-embedded (FFPE) tumor block. An H & E will be cut and stained, and assessed by an HPA pathologist.
FFPE block or slides
Fluorescence in situ hybridization (FISH)
>15% of nuclei scored displaying rearrangement a minimum of one 5’ and one 3’ ROS1, or a deletion of one 5’ROS1 only.
Results will be reported as either Positive or Negative for ROS1 rearrangement, or Uninformative.