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FDA-approved companion diagnostic

Dako EGFR pharmDx Kit

Qualitative IHC kit that detects EGFR (HER1) protein in FFPE colorectal cancer tissue to help identify patients who may be eligible for EGFR-targeted therapy.

IVD-developed CDxMethod: IHCSpecimen: Tissue (FFPE)Biomarker: EGFR
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
P030044
Supplements
S002
Manufacturer
Dako North America, Inc. (Agilent Technologies, Inc.)
Approval date
February 12, 2004
Test specifications
Methodology
IHC
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
EGFR
What this test is

Dako EGFR pharmDx Kit is an FDA-approved, qualitative immunohistochemical assay that uses a monoclonal anti-EGFR (HER1) antibody to assess membrane EGFR expression in formalin-fixed, paraffin-embedded colorectal cancer tissue. The kit provides all reagents and a standardized staining protocol, reporting EGFR-positive or -negative status to support selection of appropriate EGFR-targeted treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Colorectal Cancer (CRC)EGFR (HER1)protein expressionERBITUX, VECTIBIX

IVD Manufacturer

Dako North America, Inc. (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 forDako EGFR 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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