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FDA-approved companion diagnostic

PathVysion HER-2 DNA Probe Kit

Dual-color FISH assay that measures HER2 gene amplification in FFPE breast cancer tissue to determine HER2 status and support HER2-targeted treatment decisions.

IVD-developed CDxMethod: FISHSpecimen: Tissue (FFPE)Biomarker: HER2 gene amplification
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
P980024
Supplements
Manufacturer
Abbott Molecular, Inc.
Approval date
December 11, 1998
Test specifications
Methodology
FISH
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
HER2 gene amplification
What this test is

PathVysion HER-2 DNA Probe Kit is an FDA-approved, dual-color fluorescence in situ hybridization (FISH) assay that uses HER2 and chromosome 17 centromeric DNA probes to assess HER2 gene amplification in formalin-fixed, paraffin-embedded breast cancer tissue. It reports HER2/CEP17 ratios to classify tumors as HER2-negative or HER2-amplified and support treatment planning.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerERBB2 (HER2)gene amplificationHERCEPTIN

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 forPathVysion HER-2 DNA 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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