Test Method

Molecular

CPT Codes

81315



Test Description

This test uses RT-PCR for quantitative detection of the t(15;17) PML-RARA fusion transcript to detect both short and long isoforms of the fusion. Positive results find the isoform and quantify it as a ratio with the amount of transcript from a normal control gene. The (15;17) translocation occurs in nearly all cases of acute promyelocytic leukemia (APL, or AML subtype M3) and correlates to a high rate of 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 aspirate: 1-2 mL in EDTA tube (purple top) preferred; ACD (yellow top) acceptable
  • Peripheral blood: 5-10 mL in EDTA tube (purple top) preferred; ACD (yellow top) acceptable
  • Fresh Tissue: Minimum of 250 mg tissue in RPMI transport media
  • Formalin-Fixed Paraffin-Embedded Tissue: 1 H&E slide and 6-8 unstained slides, 5-7 microns of BM clot or tissue fixed with 10% NBF fixative. Please circle tumor for microdissection. alternatively, the FFPE clock of the BM clot can be sent for sectioning in our lab

Storage & Transport

Ship specimen the same day whenever possible, with refrigerated (not frozen) cold pack.

Label all tubes with at least two unique patient identifiers. Slides require one patient identifier. Identifiers include name, DOB, specimen ID# or medical record#.

Turnaround time

5 - 7 days

Level of Service

Global