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

or

a formalin-fixed, paraffin-embedded (FFPE) tumor block. An H & E will be cut and stained, and assessed by an HPA pathologist.

• Specimen should be fixed in 10% neutral buffered formalin for 6 - 72 hours

FFPE block or slides

• Cytogenetics oncology requisition or pathology Add-on form
• Document time in fixation – specimen should be fixed in 10% neutral buffered formalin for 6 - 72 hours

Ambient

• Improper label (unlabeled or mislabeled)
• Wrong container (anticoagulant or solution)
• Improper storage
• Leaking container
• Slides broken beyond repair

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.