To Identify patients with late-stage, non-small cell lung cancers who may benefit from treatment with Xalkori (crizotinib).

Chromosomal translocations involving the ALK gene (located at G-band region 2p23) are responsible for approximately 3-5% of non-small-cell lung cancers (NSCLC). The vast majority of these cases are adenocarcinomas. Lung cancers exhibiting ALK rearrangements are resistant to epidermal growth factor receptor tyrosine kinase inhibitors, but may be highly sensitive to ALK inhibitors, like Xalkori (crizotinib), leading to increased survival in these patients.

Sterile container filled with sterile culture medium, sterile Hanks Balance Salt Solution (HBSS) or sterile saline.

Specimens should be immersed in sterile culture medium, sterile Hanks Balance Salt Solution (HBSS) or sterile saline within one (1) hour of the procedure

Sterile container filled with sterile culture medium, sterile Hanks Balance Salt Solution (HBSS) or sterile saline.

Formalin vial

Specimens should be immersed in formalin within one (1) hour of the procedure

1. Fix the tissue in 10% neutral buffered formalin for 6 - 72 hours
2. Prepare a formalin-fixed, paraffin-embedded (FFPE) tissue block

Either the entire block (an H&E will be cut and stained, and assessed by an HPA pathologist), or two (2) 5 micron cuts mounted on positively charged slides and one (1) H&E stained slide can be submitted for testing

Formalin-fixed paraffin-embedded (FFPE) tissue block or

5 micron cuts mounted on positively charged slides

• Cytogenetics oncology requisition or Pathology Add-on requisition

Ambient

• Improper label (unlabeled or mislabeled)
• Wrong container (anticoagulant or solution)
• Improper storage
• Leaking container

Fluorescence in situ hybridization (FISH)

>15% of nuclei scored displaying rearrangement a minimum of one 5’ and one 3’ ALK, or a deletion of one 5’ALK only.

Results will be reported as either Positive or Negative for ALK rearrangement, or Uninformative.