Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are neoplastic hematological disorders that arise from myeloid progenitor cells in the bone marrow. AML is characterized by the clonal expansion of myeloid blasts in the peripheral blood, bone marrow or other tissues, while MDS is characterized by the simultaneous proliferation and apoptosis of hemopoietic cells1.
According to the World Health Organization (WHO), the global incidence for MDS is 3-5 cases per 100,000 (non-age corrected) with approximately 10,000 new cases of MDS diagnosed annually in the USA1. The Surveillance Epidemiology and End Results (SEER) statistics present a similar picture for AML with a USA incidence of 4.3 per 100,000 (non-sex specific)2.
Our range of CytoCell® FDA-cleared Class II IVD FISH probe test kits have been specifically designed to detect common chromosomal rearrangements reported in AML and MDS.
Watch the recommended protocol for our CytoCell FDA-cleared hematology FISH probes for AML and MDSEvaluate one of our CytoCell FDA-cleared hematology FISH probes today
The AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit consists of a 156kb probe labeled in Texas Red, centromeric to the AML1 (RUNX1) gene, including the CLIC6 gene; a 169kb probe labelled in Texas red, telomeric to AML1 (RUNX1) gene, extending beyond the marker D21S1921; and two (151kb and 194kb) probes, labeled inn FITC green, on either side of the ETO (RUNX1T1) gene.
View ProductThe CBFβ (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit consists of a 617kb probe, labeled in Texas Red, covering a region, within 16q22 including the CBFB gene; and a 621kb probe, labeled in FITC green, covering a region within 16p13.1 including the MYH11 gene.
View ProductThe Del(5q) Deletion FISH Probe Kit consists of a 186kb probe, labeled in Texas Red, covering a region within 5q31.2, including the D5S500 marker; and a 376kb probe, labeled in FITC green, within 5p15.3, including the D5S630 marker.
View ProductThe Del(7q) Deletion FISH Probe Kit consists of a 396kb probe, labeled in Texas Red, covering a region within 7q22 including the telomeric end of the RELN gene and extending beyond the D7S658 marker; and a 203kb probe, labeled in FITC green, covering a region within 7q31.2 including the TES gene.
View ProductThe Del(20q) Deletion FISH Probe Kit consists of a 331kb probe, labeled in Texas Red, covering a region within the PTPRT gene and including the D20S108 marker; and two (141kb and 174kb) probes labeled in FITC green covering the MYBL2 gene and including the D20S150 marker.
View ProductThe EVI1 (MECOM) Breakapart FISH Probe Kit consists of a 158kb probe, labeled in Texas Red, telomeric to the D3S4415 marker and including the LRRC34 gene, a FITC green probe covering a 181kb region, including the entire EVI1 (MECOM) gene and flanking regions and a PF-415 blue probe, which covers a 563kb region centromeric to the EVI1 (MECOM) gene, including the D3S1614 marker.
View ProductThe 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.
View ProductThe P53 (TP53) Deletion FISH Probe Kit consists of a 161kb probe, labeled in Texas Red, covering the whole P53 (TP53) gene, extending 74kb telomeric to the gene and covering a region centromeric to the gene, to just beyond the marker D17S655; and a probe, labelled in FITC green, covering the chromosome 17 centromere (D17Z1) region.
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CytoCell®: For In Vitro Diagnostic Use. Rx only. This product has not been validated for use on sample types other than bone marrow specimens, and has not been validated on disease types other than AML or MDS. The CytoCell AML/MDS range of FISH probe test kits are fluorescence in situ hybridization (FISH) tests used to detect common chromosomal rearrangements in fixed bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The tests are indicated for the characterization of patient specimens consistent with World Health Organization guidelines for Classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th Edition) and in conjunction with other clinicopathological criteria. The assay results are to be interpreted by a qualified pathologist or cytogeneticist. The tests are not intended for use as a stand-alone diagnostic, disease screening, or as a companion diagnostic.
Refer to individual test kit Package Insert for the specific intended use and limitations.
The CytoCell AML/MDS range of FISH probe test kits are for sale in the US only. These products have not been licensed in accordance with Canadian law.
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