FDA-approved companion diagnostic

HercepTest

Semi-quantitative IHC assay that measures HER2 protein overexpression in FFPE breast and gastric cancer tissue to determine HER2 status for treatment planning.

IVD-developed CDxMethod: IHCSpecimen: 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
P980018
Supplements
S010, S015, S016
Manufacturer
Dako Denmark A/S (Agilent Technologies, Inc.)
Approval date
September 25, 1998
Test specifications
Methodology
IHC
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
HER2
What this test is

HercepTest is an FDA-approved, semi-quantitative immunohistochemical assay that detects HER2 protein overexpression in formalin-fixed, paraffin-embedded breast cancer and gastric or gastroesophageal junction adenocarcinoma tissue. Using standardized 0–3+ membrane staining scores, it classifies tumors as HER2-negative, equivocal, or positive to support accurate HER2 status assessment and downstream testing or treatment decisions.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerERBB2 (HER2)HER-2 protein overexpressionHERCEPTIN, KADCYLA, PERJETA
Gastric and Gastroesophageal CancerERBB2 (HER2)HER-2 protein overexpressionHERCEPTIN

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 forHercepTest 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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