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FDA-approved companion diagnostic

Vysis ALK Break Apart FISH Probe Kit

Dual-color break-apart FISH assay that detects ALK gene rearrangements in FFPE NSCLC tissue to determine ALK status and support targeted treatment decisions.

IVD-developed CDxMethod: FISHSpecimen: Tissue (FFPE)Biomarker: ALK gene rearrangement
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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
P110012
Supplements
S020
Manufacturer
Abbott Molecular, Inc.
Approval date
August 26, 2011
Test specifications
Methodology
FISH
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
ALK gene rearrangement
What this test is

Vysis ALK Break Apart FISH Probe Kit is an FDA-approved, dual-color fluorescence in situ hybridization assay that uses break-apart DNA probes targeting the ALK locus in FFPE non–small cell lung cancer tissue. By detecting split or isolated ALK signals, it identifies ALK gene rearrangements and classifies tumors as ALK positive or negative to guide ALK-directed treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Non-Small Cell Lung Cancer (NSCLC)ALKgene rearrangementsALUNBRIG, ENSACOVE, XALKORI

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 ALK Break Apart 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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