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.
Monosomy of chromosome 7 and deletions of the long arm of chromosome 7 are recognized recurrent chromosomal aberrations frequently seen in myeloid disorders, including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)1. Furthermore, these abnormalities occur in MDS and AML that develop in patients with constitutional disorders (e.g., Fanconi anemia, Kostmann syndrome, neurofibromatosis type 1, and familial monosomy 7)2. The presence of monosomy 7 or del(7q) as karyotypic change is associated with a poorer outcome in myeloid malignancies1,3. Deletions of chromosome 7 are typically large with heterogeneity in the breakpoints in myeloid diseases, making it difficult to map the common deleted regions (CDRs)4.
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 7q22 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.
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.
The quality of the products we have received from CytoCell have been excellent. The FISH probes they provide to us give intense, strong signals and are a pleasure to count. What has really stood out however has been the level of support and assistance provided by CytoCell’s application specialists. The team worked very closely alongside our own during the adoption of this product and spent many hours with us perfecting the technique, going above and beyond what I would expect during the transition period. Source BioScience absolutely demand high quality products and service to be able to deliver our results with confidence, and that is what we have received from CytoCell.
Neil Ryan
Laboratory Operations Manager, Source BioScience, UK
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