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ALK 2p23 Rearrangement, paraffin

Test ID: FP ALK CPT Code: 88377
Expected Turnaround Time
5 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Clinical Information
FISH testing on paraffin-embedded cells for detection of ALK (2p23) gene rearrangement. ALK is frequently rearranged in non-small cell lung cancer (NSCLC). Patients with ALK-rearranged NSCLC may benefit from treatment with directed tyrosine kinase inhibitors. Often ordered in conjunction with FP ROS1.
Requisition Forms
Oncology Pathology Requisition

Specimen Requirements

Specimen Requirements
  • FFPE Tissue Block
  • Unstained FFPE tissue: 5 slides preferred (3 slides minimum) cut at 3-5 μM and mounted on positively charged slides. 
Specimen Stability

Stable indefinitely

Storage Requirements

15°C to 25°C

Shipping Conditions
Ambient
Shipping Recommendations

AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen. Do not freeze.

Specimen Rejection Criteria

Improper fixative; Tissue not fixed; Insufficient tissue; Specimen exposed to extreme temperature

Test Details

Synonyms

2p23 rearrangement; EML4-ALK, Non-small cell lung cancer, ALK-positivity

Keywords
Fluorescence in-situ Hybridization, Oncology, Oncology FISH Probes, Lymphoma, Mutation Analysis, Lung Cancer, Genomics
Test Method
Fluorescence in situ hybridization (FISH)
Methodology Category
FISH
Regulatory Status
ASR
Special Considerations

Tissues should be fixed in 10% neutral buffered formalin (NBF). Tissues preserved in B+ fixative or decalcified are usually not suitable for FISH. Assay requires 3 unstained slides minimum (two for each probe) and one H&E stained slide. If unstained slides are sent, cut FFPE tissue sections at 3-5 μm thickness, mounted on positively charged slides. 

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.