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PML-RARA Translocation, t(15;17)
- Molecular
This test uses 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 t(15;17) translocation results in the expression of a chimeric mRNA, PML-RARA; which is considered diagnostic for acute promyelocytic leukemia (APL). Two major forms of this fusion transcript have been described, long and short. Identification of these fusion transcripts is essential in APL because it is closely correlated with responsiveness to treatment with all-trans retinoic acid or other specific therapy which substantially improves survival of patients with the disease.
Presence of this abnormality in AML is associated with excellent outcome. This assay is recommended for confirmation of diagnosis and for monitoring minimal residual disease (MRD) and predicting relapse. For monitoring MRD, we recommend monitoring trend rather than making conclusion based on one measurement.
Specimen Requirements
Bone Marrow Aspirate: 2 mL in EDTA tube.
Peripheral Blood: 5 mL in EDTA tube.
Note: Test is RNA-based. Please select Extract & Hold - RNA If specimen hold service is desired.
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. NYS clients please provide date and time of Collection. Please select Extract & Hold - RNA if specimen hold service is desired.
CPT Code(s)*
81315
*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.
Last Updated: August 27, 2025