Oncology FISH Analysis - PML/RARA: t(15;17) [AML]

Clinical Use

Use

Oncology FISH Analysis - PML/RARA: t(15;17) is designed to detect a chromosomal rearrangement common in acute myeloid leukemia (AML). The assay is especially relevant for patients suspected of having AML, including those with cytogenetic testing failures or for monitoring treatment responses. The presence of the LSI PML/RAR-alpha translocation indicates a favorable prognosis, found predominantly in acute promyelocytic leukemia cases. Medical professionals must interpret results in conjunction with clinical and pathological data to ensure accurate diagnosis and treatment management. This test plays a vital role in the prognostic evaluation of patients diagnosed with this type of leukemia, aiding in refined therapeutic approaches and outcomes assessment.

Special Instructions

To collect the sample, draw bone marrow in a Sodium Heparin (green-top) tube and send 3-5 cc for adults/children or 2 cc for infants under 2 years. Samples must be shipped at ambient temperature (18-25°C) and should arrive at the laboratory within 48 hours of collection. It is important to avoid heating or freezing the specimens, ensuring accuracy in test results.

Limitations

This FISH assay detects rearrangements involving PML and RARA loci but cannot identify additional partner chromosomes. The specificity of the test means results should not solely define the diagnosis of acute myeloid leukemia, as other cytogenetic abnormalities may exist that are not assessable via this single test. Therefore, reliance on this assay alone is inadequate for conclusive diagnostics.

Test Details

Methodology

Chromosomal / Cytogenetics (FISH)

Biomarkers

2 components

Primary Component • FISHFISH Analysis • FISH

Result Turnaround Time

2-4 days

Specimen

Bone Marrow (Fresh)

Volume

3-5 cc (Adults/Children) or 2 cc (Infants< 2 years)

Minimum Volume

2 cc

Container

Sodium Heparin (green-top) tube

Collection Instructions

Draw bone marrow in a Sodium Heparin (green-top) tube(s).

Storage Instructions

Ship at ambient temperature (18-25°C/64-77°F) in an insulated container by overnight courier. Specimen should arrive in the laboratory within 48 hrs of collection. Do not heat or freeze.