Vysis Chronic Lymphocytic Leukemia (CLL) Panel
Companion Diagnostic
Vysis Chronic Lymphocytic Leukemia (CLL) Panel is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
The Vysis CLL FISH Probe Kit is a test to detect deletion and gain of specific probe targets in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL). It is particularly indicated for detecting TP53 deletion (17p-) as an aid in identifying CLL patients for whom treatment with VENCLEXTA® (venetoclax) is indicated.
Special Instructions
This test is available for use in clinical trials or research purposes only. 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.
Limitations
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Clotted specimen, specimen exposed to extreme temperature, anticoagulant toxic to cells, or insufficient number of cells will lead to specimen rejection.
FDA ApprovedCompanion Diagnostic
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
Result Turnaround Time
5 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
5 mL
Minimum Volume
Not provided
Container
EDTA preferred (NaHep accepted)
Storage Instructions
2°C to 25°C
Causes for Rejection
Clotted specimen; Specimen exposed to extreme temperature; Anticoagulant toxic to cells; Insufficient number of cells
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 72 hours |