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EML4 ALK Gene Fusion, PCR [16344]
MessageFor Specimen Integrity during Extreme Weather see the “Lockbox Usage in Extreme Weather” document at the top of this page.
Test Code
EML4
Alias/See Also
16344
CPT Codes
81401
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block
Transport Temperature
Room temperature
Specimen Stability
Room temperatue: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Refrigerated: Indefinitely
Frozen: Unacceptable
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
Set up: Tues, Fri a.m.; Report available: 2 days
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-San Juan Capistrano, CA |
33608 Ortega Highway |
San Juan Capistrano, CA 92675-2042 |
Last Updated: November 29, 2021