EML4 ALK Gene Fusion, PCR

Test Code

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

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

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.