PML/RARA t(15;17) by FISH : 1003142

Message
Please provide most recent Pathology report.


Test Code
MDFCPPMLRAFG or 1003142


Alias/See Also
Acute Myeloid Leukemia (AML); Acute Promyelocytic Leukemia (APL); AML-M3; APL (Acute Promyelocytic Leukemia); FISH (Fluorescence In Situ Hybridization); PML/RARA; t(15:17)


CPT Codes
88271, 88275

Instructions
Bone Marrow aspirate in a green top sodium heparin tube (2-3 mL) or Peripheral Blood in a green top sodium heparin tube (2-10 mL). Tissue also accepted.


Transport Container
Blood or Bone Marrow: Do not centrifuge. Paraffin embedded formalin fixed tissue that has been fixed in 10% neutral buffered formalin for at least 6 hours and no longer than 48 hours. Two unstained slides, with tissue of 4 microns in thickness are needed for processing, accompanied by a circled H & E clearly indicating the area to be examined.


Transport Temperature
Blood or Bone Marrow: Ambient temperature within 24 hours. Specimen can be refrigerated if not transported immediately. Do not freeze. Protect from heat with a cold pack. Paraffin embedded tissue block: Ambient or on ice pack in summer. Slides: Ambient.


Specimen Stability
Blood and Bone Marrow: Ambient: 48 hours; Refrigerated: 48 hours; Frozen: Unacceptable

Paraffin embedded tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable


Methodology
Fluorescence in situ hybridization (FISH)

Setup Schedule
Sunday - Saturday


Report Available
Up to 7 days
1-2 days for new diagnosis


Limitations
Laboratory test results should always be considered in the context of clinical observations. This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration
(FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.


Reference Range
An interpretive report will be provided.


Clinical Significance
t(15;17) is a chromosome abnormality found in the M3 subtype of acute promyelocytic leukemia (APL), according to the FAB (French-American-British) classification. APL represents about 10% of AML (acute myeloid leukemia). At the molecular level, this aberration results in the fusion of the PML (promyelocytic leukemia) gene at chromosome band 15q22, and RARA (retinoic acid receptor, alpha) gene at chromosome 17q21.


Performing Laboratory
med fusion



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.