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

Test Code
12628


CPT Codes
88271 (x2), 88275<br>Restricted Client Code - Tech Only

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


Minimum Volume
1 mL


Other Acceptable Specimens
Whole blood or bone marrow collected in: sodium heparin (royal blue-top) tube, 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.

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
⁠⁠⁠⁠⁠⁠⁠See Instructions


Methodology
Fluorescence in situ Hybridization

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


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.