Alternative Name
PML-RARA Translocation, PML-RARA Fusion
Methodology
Molecular
Test Description

Real-time RT-PCR for quantitative detection of the t(15;17) PML-RARA fusion transcript. Both long and short isoforms of the fusion transcript are detected. Positive results identify the isoform and quantify it as a ratio with the amount of transcript from a normal control gene. Analytical sensitivity is 1 tumor cell in 10,000 normal cells.

Clinical Significance

The (15;17) translocation occurs in nearly all cases of acute promyelocytic leukemia (APL, or AML subtype M3). The translocation is associated with a high rate of complete remission due to sensitivity of leukemic cells to all trans-retinoic acid (ATRA). This assay is recommended for diagnostic confirmation and initiation of ATRA therapy, for monitoring minimal residual disease, and for detection of relapse

Specimen Requirements

Bone marrow (preferred): 2 mL in EDTA tube. Peripheral blood (acceptable): 5 mL in EDTA tube.

Storage and Transportation

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

CPT Code(s)*
81315x1
Turnaround Time

7 days

Level of Service
Global

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.