The Vysis CLL FISH Probe Kit is a test to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence probe target via fluorescence in situ hybridization (FISH) in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL) to aid in identifying those patients eligible for treatment with Venclexta® (venetoclax).

Vysis CLL FISH Probe Kit Contents

This kit contains five reagents sufficient to process 20 assays.

An assay is defined as one 22 mm x 22 mm Vysis LSI TP53 SpectrumOrange/ATM SpectrumGreen probe hybridization area and one 22 mm x 22 mm Vysis LSI D13S319 SpectrumOrange/13q34 SpectrumAqua/CEP 12 SpectrumGreen probe hybridization area.

Each kit includes:

• Vysis LSI D13S319 SpectrumOrange/LSI 13q34 SpectrumAqua/CEP 12 SpectrumGreen Probes (1 vial, 200 µL/vial)

   

• Vysis LSI TP53 SpectrumOrange/LSI ATM SpectrumGreen Probes (1 vial, 200 µL/vial)

   

• DAPI II Counterstain (1 vial, 600 µL/vial)

   

• NP-40 (2 vials, 200 µL/vial)

   

• 20X Standard Sodium Citrate (SSC) Salt (1 bottle, 66 g)

Intended Use

The Vysis CLL FISH Probe Kit is a test to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence probe target via fluorescence in situ hybridization (FISH) in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).

Indications For Use

In untreated patients, the assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology, and other clinical information. The test is indicated for detecting deletion of the LSI TP53 probe target (17p-) as an aid in identifying those patients with CLL for whom treatment with VENCLEXTA® (venetoclax) is indicated. Vysis CLL FISH Probe Kit is not intended for monitoring of residual disease.

The test is for prescription use only

Limitations of the Procedure

• When used to select CLL patients for treatment with VENCLEXTA® (venetoclax), the test is validated for peripheral blood specimens anticoagulated with sodium heparin only.
• The Vysis CLL FISH Probe Kit is intended to be used in combination with additional biomarkers, morphology, and other clinical information.
• Other signal patterns may occur, and metaphase analysis may be helpful in characterization of such patterns.
• If a specimen has a low level abnormal FISH pattern, use of the appropriate single pass filter(s) to confirm the pattern is recommended. Failure to follow this recommendation may result in inaccurate identification of signal patterns.

Rx Only

For In Vitro Diagnostic Use

To learn more about the Vysis CLL FISH Probe Kit please visit: https://www.molecular.abbott/us/en/products/oncology/vysis-cll-fish-probe-kit