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FDA-approved companion diagnostic

Vysis CLL FISH Probe Kit

Multi-color FISH panel that detects key chromosomal abnormalities in CLL cells to support diagnosis, risk stratification, and treatment planning.

IVD-developed CDxMethod: FISHSpecimen: Whole bloodBiomarker: 4 genes
Ready to order?

Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P150041
Supplements
Manufacturer
Abbott Molecular, Inc.
Approval date
April 11, 2016
Test specifications
Methodology
FISH
Specimen
Whole blood
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
What this test is

Vysis CLL FISH Probe Kit is a multi-color fluorescence in situ hybridization assay that uses locus-specific DNA probes to detect common cytogenetic abnormalities in chronic lymphocytic leukemia, including deletions at 13q, 11q, and 17p and trisomy 12. Applied to peripheral blood or bone marrow cells, it identifies CLL-associated rearrangements to aid diagnosis and prognostic assessment.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
B-cell Chronic Lymphocytic Leukemia (CLL)TP53Deletion chromosome 17p (17p-)VENCLEXTA

IVD Manufacturer

Abbott Molecular, Inc.

Abbott Molecular is a leader in molecular diagnostics — the analysis of DNA and RNA at the molecular level. Its tests can detect subtle genetic and chromosomal changes that may aid earlier diagnosis, guide therapy selection, and help monitor disease progression.

Order this test

If your organization is connected to Casandra, you can place an electronic order forVysis CLL FISH Probe Kit directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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