Test Overview

Test Methodology

Reverse transcription followed by Real-Time Polymerase Chain Reaction (PCR)

Test Usage

Greater than 95% of acute promyelocytic leukemia (APL) cases harbor a t(15;17) translocation. This rearrangement results in the fusion of the PML and retinoic acid receptor alpha (RARA) genes located on chromosomes 15 and 17 respectively. Three breakpoint regions within the PML gene can be involved, resulting in three possible PML/RARA fusion types: bcr1 (long), bcr2 (variable), and bcr3 (short). This test qualitatively detects all three PML/RARA transcript variants in peripheral blood and bone marrow. Testing for PML/RARA can assist in the diagnosis, clinical management, and monitoring of APL.

Reference Range*

Interpretive report provided.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

The limit of detection of this assay is 1/5,000 to 1/10,000 cells carrying the PML/RARA fusion. Mutations may not be detected in samples with a neoplastic burden below this level. This assay will not detect atypical rearrangements outside of the tested breakpoint regions or rearrangements involving uncommon RARA fusion partners such as NPM1, STAT5B, NUMA, PLZF. Specimens older than 48-72 hours may result in failed testing due to RNA degradation.

Test Details

Days Test Performed

Monday - Friday

Analytic Time

2 - 7 days

Soft Order Code

PML

MiChart Code

PML/RARA t(15;17) Translocation

Synonyms

Synonyms

t(15;17) Translocation
MLABEL
PMRAR
PML
PML/RARA TRANSLOCATION ASSAY
t(15;17) PML RARa RQ PCR
PMLRAR
PML-RAR alpha RT-PCR

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Laboratory

Molecular Diagnostics

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Specimen Requirements

Offsite Collection Instructions

Collect blood or bone marrow in a lavender top tube. Refrigerate and send intact blood or bone marrow specimen within 48 hours of collection. Fresh tissue (preferably 0.5cm3, sent in RPMI) and fresh aspirates or body fluids are acceptable. Refrigerate and send, preferably within 24 hours. Frozen tissue specimens – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice. Fresh cell suspensions in RPMI should be refrigerated and sent, preferably within 48 hours. Frozen cell suspensions – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice.

Container

Lavender Top Tube

Normal Volume

5 mL EDTA (lavender) whole blood; 3 mL EDTA (lavender) bone marrow; Fresh/frozen tissue and fresh aspirates or body fluids; Fresh/frozen cells in RPMI. Extracted RNA is also acceptable if extracted in a CLIA certified laboratory.

Additional Information

This test is qualitative; requests for quantitative analysis will be sent to TriCore Reference Laboratory. By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs to report the test results to the ordering clinician. Test includes pathologist interpretation of results billed as a separate additional charge. This test is not available without interpretation.

Billing Information

Fee Codes


CPT Code

81315

New York State Approved

No

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