Vysis EGR1 FISH Probe Kit – SC

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:

• Vysis LSI EGR1 SpectrumOrange/D5S23, D5S721 SpectrumGreen Probes
• 1 vial, 20 μl per vial (100 and 300 ng/μL)

• Vysis LSI/WCP Hybridization Buffer
• 1 vial, 150 μl per vial
• DAPI II Counterstain
• 1 vial, 600 μL per vial (125 ng/mL)
• NP-40
• 2 vials, 2000 μl per vial
• 20x Standard Sodium Citrate (SSC) Salt
• 1 bottle, 66 g 

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 

• FOR IN VITRO DIAGNOSTIC USE ONLY.
• The Vysis EGR1 FISH Probe Kit - SC is intended to be used in combination with additional biomarkers, morphology, and other clinical information.
• If a specimen has an overall low signal intensity FISH pattern and a low level of cells with an atypical (1R2G) FISH signal pattern, use of the appropriate single-pass filter to confirm the pattern is recommended. Failure to follow this recommendation may result in inaccurate identification of signals.
• Other abnormal signal patterns may occur, and metaphase analysis may be helpful in characterization of such patterns.

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

• A study comparing the Vysis LSI EGR1 SpectrumOrange/ D5S23,D5S721 SpectrumGreen Probes to metaphase cytogenetics to detect loss of 5q, in both MDS and AML, concluded while cytogenetics detected most instances of del (5q), fluorescence in situ hybridization (FISH) was especially useful in cases with suboptimal growth, and EGR1 FISH detects del(5q) in a broad variety of myeloid neoplasms. 
• A study investigating whether monosomy 5, identified by G-banded karyotyping, truly existed in 28 cases of MDS or AML, found del(5q) in 24 cases and monosomy 5 in only 3 cases. This study concluded EGR1 FISH, using the Vysis LSI EGR1 SpectrumOrange/D5S23,D5S721 SpectrumGreen Probes, can complement conventional cytogenetics and improve the karyotype definition. 
• A study, conducted as part of an Eastern Cooperative Oncology Group (ECOG) clinical trial, showed that FISH detection of specific aberrations using several Vysis FISH probe sets including the Vysis LSI EGR1 SpectrumOrange/D5S23,D5S721 SpectrumGreen Probes, was highly correlated to cytogenetic discovery of these same aberrations in AML patients. 
• The Vysis EGR1 FISH Probe Kit – SC uses FISH DNA probe technology to detect the probe target for LSI EGR1, and the LSI D5S23, D5S721 probe serves as a control.