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FDA-approved companion diagnostic

HER2 FISH pharmDx Kit

Direct FISH assay that quantifies HER2 gene amplification in FFPE breast and gastric cancer tissue to assess HER2 status and support HER2-targeted treatment planning.

IVD-developed CDxMethod: FISHSpecimen: Tissue (FFPE)Biomarker: HER2
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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
P040005
Supplements
S005, S006, S009
Manufacturer
Dako Denmark A/S (Agilent Technologies, Inc.)
Approval date
May 3, 2005
Test specifications
Methodology
FISH
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
HER2
What this test is

HER2 FISH pharmDx Kit is an FDA-approved, direct fluorescence in situ hybridization (FISH) assay that quantitatively determines HER2 gene amplification in formalin-fixed, paraffin-embedded breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma tissue. It reports HER2/CEP17 ratios to classify HER2 status and support treatment decision-making.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerERBB2 (HER2)gene amplificationHERCEPTIN, KADCYLA, PERJETA
Gastric and Gastroesophageal CancerERBB2 (HER2)gene amplificationHERCEPTIN

IVD Manufacturer

Dako Denmark A/S (Agilent Technologies, Inc.)

Agilent Technologies Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.

Order this test

If your organization is connected to Casandra, you can place an electronic order forHER2 FISH pharmDx 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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