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P53 (TP53) Deletion

Fda cleared
Applications
hematology
Area of Interest
AML, MDS
Catalogue Numbers
USA-LPH 017 (10 tests)

The TP53 (tumor protein p53) gene at 17p13 is a tumor suppressor gene that has been shown to be deleted in a wide range of human malignancies. In acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), TP53 loss is associated with a poor outcome and is often seen as a marker of disease progression or secondary disease1,2.

Intended Use

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 17 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.

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. Grimwade D et al., Blood. 2010;116(3):354–65.

2. Seifert H et al., Leukaemia. 2009;23(4):656–63.

Microscope Images

P53 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