Inv(16)(p13.1q22);CBFB-MYH11 Fusion Transcript Detection

Quantitative RNA-PCR

Indication

For determining the presence or absence of the CBFB-MYH11 fusion transcript associated with the inv(16(p13.1q22) chromosomal abnormality seen in 5 to 8% of acute myeloid leukemia (AML) cases as defined by the 2008 WHO classification and AML-M4Eo cases per the 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 CBFB-MYH11 fusion by reverse transcription followed by quantitative real-time PCR using the TaqMan method.

Test Parameters

This assay will detect the Type A CBFB-MYH11 fusion transcripts. Values are expressed as a percentage of CBFB-MYH11 to normalizing ABL 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.