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Alternative Name
PML-RARA Translocation Liquid Biopsy Testing
Test Description

Real-time RT-PCR for quantitative detection of the t(15;17) PML-RARA fusion transcript using cell-free plasma DNA/RNA. Both long and short isoforms of the fusion transcript are detected.

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. In addition, this test can be used for screening and determining if a bone marrow biopsy is an absolute necessity. It can also be used for performing molecular studies when a bone marrow sample is inadequate (dry tap, insufficient quantity, or not viable), or not available.

Specimen Requirements
  • Peripheral blood: 2 x 6 mL EDTA tubes (total 12 mL) or 10 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)*
Turnaround Time

7 days

Level of Service

*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.