Detection of ALK gene rearrangements by fluorescence in situ hybridization (FISH) may be demonstrated in different types of cancers. Recent studies have demonstrated that the determination of the presence of ALK gene rearrangements helps treating physicians select more effective therapies for patients with non-small cell lung cancer (NSCLC).
Based on current literature, the determination of ALK gene arrangements identify patients that may not benefit from targeted therapeutics like epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) such as erlotinib.
ALK gene rearrangements define a distinct molecular subset of NSCLC that is mutually exclusive from EGFR and KRAS mutations.
Studies have also found that metastatic patients whose tumors harbor ALK mutations display similar sensitivity to platinum-based combination chemotherapy as patients without EGFR or KRAS mutations (wild-type).
The FISH test results should be used in conjunction with other clinical information. The probe used is an ALK Dual Color, Break Apart Rearrangement Probe (Vysis®).
Information Sheet - ALK Testing - NSCLC (PDF)
CPT Codes:
88271, 88275, 88291
Specimen Requirements:
1. Fixed Paraffin Block with Corresponding H&E: - Tissue should be in formalin. If alternative fixative is used, it should be noted on the requisition.
- Store specimen at room temperature (20-23.5° C).
- Use cold pack for transport. Be sure cold pack is not in direct contact with specimen during transport.
2. Unstained Slides:
- Send all slides within 6 weeks of cutting.
- Minimum of 4 slides for FISH testing (include additional slide for Genzyme H&E).
- Pre-cut slides from paraffin block in 5 micron sections and mounted on Poly-L-Lysine-coated or plus (+) slides.
- Air dry. Do not oven dry.
- Store specimens at room temperature (20-23.5° C).
Turnaround Time:
7-10 days
Client Services:
Oncology/Pathology
800-447-5816
Specimen Services/Pickup:
877-246-1226
Vysis® is a registered trademark of Abbott Molecular Inc.