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Del(7q) Deletion

Fda cleared
Applications
hematology
Area of Interest
AML, MDS
Catalogue Numbers
USA-LPH 025 (10 tests)

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.

Recommended Protocol

https://youtu.be/udHkc0t7VsA

Intended Use

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.

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. Jerez A et al., Blood. 2012 Jun 21;119(25):6109–17.

2. Fischer K et al., Blood. United States; 1997 Mar;89(6):2036–41.

3. Trobaugh-Lotrario a D et al., Bone Marrow Transplant. 2005 Jan;35(2):143–9.

4. Mcnerney ME et al., Biochem J. 2013;444(3):975–83.

Microscope Images

Del 7q 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