EML4 ALK Gene Fusion, PCR

Test Code

AP 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

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

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.