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MLL (KMT2A) Breakapart

Fda cleared
Applications
hematology
Area of Interest
AML, MDS
Catalogue Numbers
USA-LPH 013 (10 tests)

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.

Intended Use

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.

Limitations of the Procedure

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.

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representatives for availability.

References

1. Tomizawa D., Pediatr Int. 2015;4:811–9.

2. Wright RL et al., Crit Rev Oncol Hematol. 2014;91(3):283–91.

3. van der Burg M et al., Leuk Off J Leuk Soc Am Leuk Res Fund, UK. 2004;18(5):895–908.

4. Grossmann V et al., Leukemia. England; 2013. p. 1933–6.

5. Super HJ et al., Blood. United States; 1993 Dec;82(12):3705–11.

6. Schanz J et al., J Clin Oncol. 2012;30(8):820–9.

7. Tamai H et al., J Clin Exp Hematop. 2010;50(2):91–8.

Microscope Images

MLL microscope v2
Dish1Sample and Slide Preparation
Pipette2Pre-denaturation
Thermometer3Denaturation
Moon4Hybridization
Droplet5Post-Hybridization Washes
Microscope green6Analyze

For additional support and advice about the FISH technique please visit our support page