FISH, RUNX1T1/RUNX1 (ETO/AML1), Translocation (8;21), TC

Test Code

37880

Preferred Specimen

3 - 5 mL bone marrow or whole blood collected in sodium heparin (green-top), (royal blue-top) or lead-free (tan-top) tube

Minimum Volume

1 mL

Instructions

Specimen viability decreases during transit. Send specimen to testing lab for viability.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: See Instructions
Refrigerated: See Instructions
Frozen: Unacceptable

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 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.

Setup Schedule

A.M. Sets up 7 days a week.

Report Available

Reports in 5 to 7 days.

Clinical Significance

This test is performed to detect the RUNX1T1 (ETO;8q22) and RUNX1 (AML1;21q22), translocation t(8;21), by FISH (fluorescence in situ hybridization). This assay is useful for diagnosis of acute myeloid leukemia (AML) with RUNX1T1/RUNX1 (ETO/AML1) gene fusion.

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.