The MLL (KMT2A) Breakapart FISH Probe Kit consists of an 87kb probe, labeled in Texas Red, covering a region telemetric to the MLL (KMT2A) gene including the marker SHGC-111513 and a FITC green probe covering a 170kb region centromeric to the MLL (KMT2A) gene spanning the CD3G and UBE4A genes.
The KMT2A (lysine methyltransferase 2A) gene at 11q23.3 encodes for a histone methyltransferase, which functions as an epigenetic regulator of transcription1. KMT2A rearrangements are reported frequently in patients with AML and have also been reported in patients with therapy related MDS, albeit at a lower frequency2,3,4,5,6. Historically, KMT2A rearrangements in acute leukemia were associated with a poorer outcome, but recent studies have shown that the prognosis is highly dependent on the fusion partner and may differ between children and adults7. Because this is a breakapart probe, it cannot be used to determine the fusion partner.
The MLL (KMT2A) Breakapart FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect rearrangement of the MLL (KMT2A) region on chromosome 11 at location 11q23.3 in fixed bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The test is indicated for characterization of patient specimens consistent with World Health Organization (WHO) guidelines for Classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th Edition) and in conjunction with other clinicopathological criteria. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. The test is not intended for use as a stand-alone diagnostic, disease screening, or as a companion diagnostic.
For In Vitro Diagnostic Use. Rx only.
Reporting and interpretation of FISH results should be consistent with professional standards of practice and should take into consideration other clinical and diagnostic information. This kit is intended as an adjunct to other diagnostic laboratory tests and therapeutic action should not be initiated on the basis of the FISH result alone. Failure to adhere to the protocol may affect the performance and lead to false results.
Each lab is responsible for establishing their own cut-off values. Each laboratory should test sufficiently large number of samples to establish normal population distribution of the signal levels and to assign a cut-off value. The product is for professional use only and is intended to be interpreted by a qualified Pathologist or Cytogeneticist.
For sale in the US only. This product has not been licensed in accordance with Canadian law.
I first came across CytoCell FISH probes in a previous lab I worked in and I was struck by the quality of the products. Since this time, I have been recommending and introducing CytoCell probes across all application areas — now they are the primary FISH probes used in our lab. They have an excellent range of products and their ready-to-use reagent format saves considerable time.
Elizabeth Benner
Medical Technologist, University of Arizona Health Network, USA
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