MLL gene rearrangement (11q23) by FISH : 1001109

Please provide most recent Pathology report.

Test Code
MDFCPCMLLGR or 1001109

Alias/See Also
MLL breakapart; MLL

CPT Codes
88271x2, 88275

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

Fluorescence in situ hybridization (FISH)

Setup Schedule
Monday - Friday

Report Available
Up to 7 days

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
Translocations of chromosome 11 at band 11q23 with various partner chromosomes have been consistently reported in acute leukemias. The breakpoint at band 11q23 may split the gene called MLL that is responsible for the development of different lineage leukemias Rearrangements of the MLL(11q23) gene can be detected in approximately 85% of infants with B-ALL and is associated with increased risk for treatment failure. The event-free survival of AML patients with the MLL gene rearrangement appears to be worse than that of the AML patient without this abnormality.

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.