FISH, ETV6/RUNX1 (TEL/AML1), Translocation (12;21)

Test Code

14618

CPT Codes
88271 (x2), 88275

Includes

If results are not possible from the submitted specimen, the test order will be canceled and replaced with a Cytogenetics Communication.

Preferred Specimen

5 mL whole blood collected in a sodium heparin (green-top) tube, or
3 mL bone marrow collected in a sodium heparin (green-top) tube

Minimum Volume

1 mL

Other Acceptable Specimens

Whole blood or bone marrow collected in: Sodium heparin (royal blue-top) or sodium heparin lead-free (tan-top) tube

Instructions

Clinical history and reason for referral are required with test order. Prior therapy/transplant information should be submitted with test order.
Specimen Requirements: Bone marrow 1-3 mL, or whole blood 3-5 mL collected in a sodium heparin tube.

Specimen viability decreases during transit. Send specimen to testing laboratory for viability determination. Do not freeze. Do not reject.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: See Collection Instructions
Refrigerated: See Collection Instructions
Frozen: See Collection Instructions

Methodology
Fluorescence in situ Hybridization (FISH)

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: Daily; Report available: 5 days

Reference Range

See Laboratory Report

Clinical Significance

This FISH (fluorescence in situ hybridization) procedure is used to detect the ETV6/RUNX1 (TEL/AML1) gene fusion resulting from a cytogenetically undetectable t(12;21) (p13;q22) translocation which is common in pediatric pre B-ALL. This test is useful for the evaluation of suboptimal specimens, cases with a normal karyotype, or when an abnormal karyotype lacking a specific/prognostically defined abnormality or demonstrating deletion 12p is found.

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.