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Test Directory

Test Directory EML4 ALK Gene Fusion, PCR

EML4 ALK Gene Fusion, PCR

Test Summary

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.

Aliases

Specimen Collection

Special Instructions

N/A

Preferred Specimen

Formalin-fixed, paraffin-embedded tissue block

Minimum Volume

N/A

Instructions

N/A

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable

Limitations

N/A

Other Acceptable Specimens

N/A

Unacceptable Specimens

Frozen tissue block

Order Code

EML4

EPIC (Premier) Code

LAB5237

Includes

N/A

CPT Code

81401

Billing Code

670272

CPT Statement

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 the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

Not detected

Setup Schedule / Expected Turnaround Time

Tuesday, Friday morning; Report available: 2 days