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MLL gene rearrangement (11q23) by FISH : 1001109
MessagePlease provide most recent Pathology report.
Test Code
MDFCPCMLLGR or 1001109
Alias/See Also
MLL breakapart; MLL
CPT Codes
88271x2, 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
Paraffin embedded tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Methodology
Fluorescence in situ hybridization (FISH)
Setup Schedule
Monday - Friday
Report Available
Up to 7 days
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.
(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
The KMT2A (lysine methyltransferase 2A) gene, previously known as the MLL gene, on chromosome 11q23.3 encodes for a histone methyltransferase, which functions as an epigenetic regulator of transcription. KMT2A FISH (fluorescence in situ hybridization) testing is used to detect rearrangements in the KMT2A gene in patients with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), and in a small subset of patients with myelodysplastic neoplasms (MDS). KMT2A rearrangements in acute leukemia are associated with a poor outcome. However, recent studies have shown that the prognosis is dependent on the fusion partner and cell lineage origin. In addition, both adults and pediatric patients with KMT2A gene rearrangements can now benefit from a recent FDA-approved menin inhibitor therapy, particularly in cases with relapsed and refractory acute leukemia. KMT2A FISH testing is used in conjunction with other clinical and histopathological tests. It is not intended to be used as a stand-alone diagnostic.
Performing Laboratory
med fusion
