RUNX1-RUNX1T1/t(8;21) Fusion Transcript Detection (Quantitative RNA-PCR)

Indication

For determining the presence or absence of the RUNX1-RUNX1T1 (formerly known as AML1-ETO) fusion transcript associated with the t(8;21)(q22;q22) chromosomal abnormality seen in a ~5% of acute myeloid leukemia (AML) cases as defined by the 2008 WHO classification and a subset of AML-M2 cases per prior FAB classification. This quantitative test can be used for establishing the diagnosis of AML with recurrent genetic abnormalities per 2008 WHO classification and for monitoring levels of minimal residual disease following therapy.

Methodology

RNA is analyzed for RUNX1-RUNX1T1 fusion by reverse transcription followed by quantitative real-time PCR using the TaqMan method.

Test Parameters

This assay will detect RUNX1-RUNX1T1 fusion transcripts. Values are expressed as a percentage of RUNX1-RUNX1T1 to normalizing ABL1 transcripts. The sensitivity of detection is approximately 1 in 100,000.

Turnaround Time

Five to 10 working days

Sample Requirements

• 10 ml peripheral blood in purple top tube (EDTA Vacutainer), sent by overnight express mail on wet ice
  
  or
  
• 2-5 ml of bone marrow aspirate in purple top tube (EDTA Vacutainer), sent by overnight express mail, sent on wet ice

CPT Codes

81401

The CPT codes provided 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 payer being billed.