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EML4 ALK Gene Fusion, PCR
Test CodeAP EML4ALK
Quest Code
16344
CPT Codes
81401 (ZB0X8)
Preferred Specimen
Formalin-fixed paraffin embedded tissue block
Instructions
Regular procedure for paraffin embedded tissue block preparation
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Do Not Freeze
Refrigerated: Indefinite
Frozen: Do Not Freeze
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Frozen tissue block
Methodology
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
A.M.
Reference Range
Not detected
Clinical Significance
Recently, inhibitors of anaplastic lymphoma kinase (ALK) have been used successfully in treating patients harboring gene fusions between echinoderm microtubule-associated protein-like 4 (EML4) and ALK. This is a reverse transcription PCR-based exon scanning approach to encompass fusion variants spanning nearly the entire EML4 gene.
Performing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130