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FDA-approved companion diagnostic

HER2 CISH pharmDx Kit

A comprehensive genomic profiling assay used as a companion diagnostic to select patients for targeted therapies across multiple solid tumors.

IVD-developed CDxMethod: NGS (Hybrid Capture)Biomarker: Multiple genomic alterations
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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
P100024
Supplements
Manufacturer
Dako Denmark A/S (Agilent Technologies, Inc.)
Approval date
November 30, 2011
Test specifications
Methodology
NGS (hybrid capture)
Turnaround (typical)
Not specified
Report format
Comprehensive report PDF
What this test is

HER2 CISH pharmDx Kit is an in vitro diagnostic test that uses next-generation sequencing to identify genomic alterations in solid tumors. It is approved by the FDA as a companion diagnostic for multiple targeted therapies across tumor types.

Results from this assay help determine whether a patient is eligible for specific therapies based on the genomic profile of their tumor.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast 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 CISH 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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