Test Name
ALK 2p23 rearrangement, paraffin
Test Code
FP ALK
Synonyms
2p23 rearrangement; EML4-ALK; Non small cell lung cancer
Associations
The FDA has approved Crizotinib (Xalkori) for treatment of patients with locally advanced or metastatic NSCLC that is ALK-positive. The ALK Break-Apart FISH Probe Kit detects rearrangement of the anaplastic lymphoma kinase (ALK) gene in NSCLC. Up to 5
CPT Codes
88377, 88271
Turnaround Time
5
Specimen Requirements
FFPE tissue is acceptable for FISH analysis. Preferred fixative is 10% neutral buffered formalin. Tissues preserved in B5 fixative or decalcified are usually not suitable for FISH. Tumor sections cut 3-5 µm thick and mounted on positively charged organosilane coated (silanized) slides work well. Request several unstained sections (two for each probe) and one H&E stained slide
Specimen Stability
Stable indefinitely when stored at 20°C to 25°C
Storage & Handling
4°C to 25°C during transit, but specimens may be transported on refrigerated gel packs. Do not allow the gel pack to come in contact with the specimen. Do not freeze. Extreme temperatures should be avoided.
Causes for Rejections
Improper fixative; Tissue not fixed; Insufficient tissue; Specimen exposed to extreme temperature
Description
The LSI dual break-apart rearragement probe contains two differently labelled probes on either sides of the breakpoint of the ALK gene. ALK has multiple fusion partners including NPM in anaplastic large cell lymphoma and EML4 in non small cell lung cancer
References
- Soda et al. (2007). Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 448:561-566
- Rodig et al.(2009) Unique clinicopathologic features characterize ALK-Rearranged Lung Adenocarcinoma in Western Population. Clin Cancer Res 15:5216-5223
- Shaw et al. (2009) Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK, JCO 26:4247-4253
- Patel Ankita et al. (2007). Cancer Genetics and Cytogenetics. 176:107-114.
- Onciu M et al. (2003). ALK-positive anaplastic large cell lymphoma with leukemic peripheral blood involvement is a clinicopathologic entity with an unfavorable prognosis. Am J Clin Pathol. 120(4):617.
- Liang X et al. (2004). Assessment of t(2;5)(p23;q35) translocations and variants in pediatric ALK+ anaplastic large cell lymphoma. Am J Clin Pathol. 121(4):496.
