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For In Vitro Diagnostic Use
The Vysis EGR1 FISH Probe Kit – SC (Specimen Characterization) detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. The Vysis EGR1 FISH Probe Kit – SC assay results characterize bone marrow specimens from patients with acute myeloid leukemia or myelodysplastic syndrome.
Vysis EGR1 FISH Probe Kit - SC (Specimen Characterization) (PDF - 1.6 MB)
For Information Only - Not a Controlled Copy
The Vysis EGR1 FISH Probe Kit – SC (Specimen Characterization) detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. The Vysis EGR1 FISH Probe Kit – SC assay results characterize bone marrow specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. This device is not intended for high-risk uses such as selecting therapy, predicting therapeutic response or disease screening. The use of this product for diagnosis, monitoring or risk assessment has not been established.
Vysis EGR1 FISH Probe Kit – SC Contents
This kit contains 5 reagents sufficient to process 20 assays.
An assay is defined as one 22 mm x 22 mm LSI EGR1/D5S23, D5S721 DNA probe hybridization area.
Each kit includes:
Indications and Limitations of Use
Intended Use
The Vysis EGR1 FISH Probe Kit – SC (Specimen Characterization) detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. The Vysis EGR1 FISH Probe Kit – SC assay results characterize bone marrow specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist.
This device is not intended for high-risk uses such as selecting therapy, predicting therapeutic response or disease screening. The use of this product for diagnosis, monitoring or risk assessment has not been established.
Limitations of the Procedure
CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; use is restricted to, by, or on the order of a physician.
Abnormalities of chromosome 5 are common aberrations in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). A commonly deleted segment on chromosome band 5q31 has been identified and the early growth response 1 (EGR1) gene is among the candidate genes in this segment. A study suggests that haplo-insufficiency of EGR1 may play a role in leukemogenesis. The Vysis locus-specific identifier (LSI) EGR1 SpectrumOrange/D5S23 , D5S721 SpectrumGreen Probes, and components of the Vysis EGR1 FISH Probe Kit – SC, have been used in several studies to detect EGR1 deletions.
Study Information
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