Vysis Chronic Lymphocytic Leukemia (CLL) Panel

Test ID: F CLL Vysis CPT Code: N/A

Biopharma: This test is available for use in clinical trials or research purposes only.

Expected Turnaround Time

5 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.

Clinical Information

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 FISH in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL). The Vysis CLL Fish probe kit 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.

Requisition Forms

Oncology Pathology Requisition

Specimen Requirements

Whole Blood: 5 mL, EDTA preferred (NaHep accepted)
Bone Marrow Aspirate: 3 mL, EDTA preferred (NaHep accepted)

Specimen Stability

72 hours

Storage Requirements

Whole Blood: 2°C to 25°C
Bone Marrow Aspirate: 2°C to 25°C
Fixed Cytogenetically Prepared Cells: -28°C to -15°C

Shipping Conditions

Ambient, Refrigerated

Shipping Recommendations

AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen. Do not freeze.

Specimen Rejection Criteria

Clotted specimen; Specimen exposed to extreme temperature; Anticoagulant toxic to cells; Insufficient number of cells

Test Details

Synonyms

LSI TP53, LSI ATM, LSI D13S319, D12Z3

Keywords

Companion Diagnostics, Fluorescence in-situ Hybridization, Leukemia, Oncology, Chronic Lymphocytic Leukemia (CLL), Oncology FISH Panels

Test Method

Fluorescence in situ hybridization (FISH)

Methodology Category

FISH

Regulatory Status

IVD, CE-marked, FDA-Approved Companion Diagnostic (CDx)

Special Considerations

All attempts will be made to process and report samples received > 72 hours post-collection. Bone marrow is the sample of choice in most heme malignancies.

Associations

Chronic Lymphocytic Leukemia (CLL)