PML-RARA/t(15;17) Fusion Transcript Detection (Quantitative RNA-PCR)

Indication

For determining the presence or absence of the PML-RARA fusion transcript that is associated with the t(15;17) chromosomal abnormality seen in AML-M3 (acute promyelocytic leukemia). This quantitative test can be used for diagnosis or for monitoring levels of minimal residual disease detection following therapy. Preliminary results suggest a 1-2 log increase in normalized PML-RARA transcript levels over 3-6 months may precede overt relapse.

Methodology

RNA is analyzed for PML-RAR fusions by reverse transcription followed by quantitative real-time PCR using the TaqMan method.

Test Parameters

This assay will detect both the long form and short form fusion transcripts. Values are expressed as a percentage of PML-RARA to normalizing ABL transcripts. The sensitivity of detection is approximately 1 in 10,000 and 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

81315

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.