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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 11g23.3 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. The P53 (TP53) Deletion FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect deletion of the P53 (TP53) region on chromosome 7 at location 17p13 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. The Del(20q) Deletion FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect deletion within the long arm of chromosome 20 at locations 20g12 and 20q13.1, in fixed bone marrow specimens from patients with 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. The CBFB (CBFB)/MYH11 Translocation, Dual Fusion FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect rearrangement of the chromosome 16 causing the CBFB-MYH11 (CBFB-MYH11) fusion in fixed bone marrow specimens from patients with acute myeloid leukemia (AML). 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. The Del(5q) Deletion FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect deletions within the long arm of chromosome 5 at location 5g31.2 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. The Del(7q) Deletion FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect deletions within the long arm of chromosome 7 at locations 7g22 and 7q31.2 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. The AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect rearrangement involving the AML1 (RUNX1) region on chromosome 21 at location 21g22.1 and the ETO (RUNXITI) region on chromosome 8 at location 8q21.3 in fixed bone marrow specimens from patients with acute myeloid leukemia (AML). 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. The EVI1 (MECOM) Breakapart FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect rearrangement involving the EVII (MECOM) region on chromosome 3 at location 3g26.2, 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 prescription use. For in vitro diagnostic use

Each Cytocell FISH Probe Kit device consists of one vial containing specific probes as described below. The probes are provided premixed in hybridization solution (formamide: dextran sulfate; saline-sodium citrate (SSC)) and are ready to use. The Kit also includes one vial of 4,6-diamidino-2-phenylindole (DAPI) counterstain. The kits are available in a 10-test format. 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 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. The 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. The CBFB (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. The 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. The 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. The AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit consists of a 156kb probe labeled in Texas red, centromeric to the AMLI (RUNXI) gene, including the CLIC6 gene; a 169kb probe labelled in Texas red, telomeric to AMLI (RUNXI) gene, extending beyond the marker D21S1921; and two (151kb and 194kb) probes, labeled inn FITC green, on either side of the ETO (RUNXIT) gene. The 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 EVI I (MECOM) gene, including the D3S1614 marker.