Effective Tuesday, May 19, 2020, PML-RARA (t(15;17)) RNA Quantitation is available by the Molecular Pathology Laboratory in the Department of Pathology.

Key features to note:

• Testing is intended to monitor levels of PML-RARA fusion transcripts during treatment in patients with acute promyelocytic leukemia positive for the t(15;17)(PML-RARA) translocation.
• The limit of quantitation is 0.01% PML-RARA/ABL1 and positive results less than 0.01% will be reported as Trace Positive. The assay can reliably detect 1 tumor cell in a background of 20,000 normal cells.

TEST: PML-RARA (t(15:17)) RNA Quantitation with Interpretation

EPIC Order Code: LAB9020

Specimen type: Whole blood (EDTA anti-coagulated; 5ml pink top tube) or bone marrow aspirates (EDTA anti-coagulated; pink or lavender top tube). DO NOT CENTRIFUGE. Store and send whole blood refrigerated.

Method: Multiplex reverse transcription in combination with droplet digital PCR is performed to detect the PML-RARA fusion transcript and normal ABL1 expression.

Results Reported:
Results are reported as a percent ratio of PML-RARA fusion transcripts to ABL1 expression. There are minimum ABL1 values for the new assay that must be met to reliably report negative results; values below that will be indicated as an insufficient specimen.

Questions concerning testing can be directed to Aaron Bossler, MD, PhD (319-384-9566) or Sharathkumar Bhagavathi, MD (319-678-8197).