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FDA-approved companion diagnostic

MAGE-A4 IHC 1F9 pharmDx

Qualitative IHC assay that detects MAGE-A4 protein expression in FFPE synovial sarcoma tissue to determine MAGE-A4 status and support selection of MAGE-A4–directed therapies.

IVD-developed CDxMethod: IHCSpecimen: Tissue (FFPE)Biomarker: MAGE-A4 protein expression
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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
P230016
Supplements
Manufacturer
Agilent Technologies, Inc.
Approval date
November 27, 2024
Test specifications
Methodology
IHC
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
MAGE-A4 protein expression
What this test is

MAGE-A4 IHC 1F9 pharmDx is an FDA-approved, qualitative immunohistochemistry assay that uses a monoclonal anti–MAGE-A4 antibody to detect nuclear and/or cytoplasmic MAGE-A4 protein expression in FFPE synovial sarcoma tissue. It reports a MAGE-A4 Tumor Intensity Proportion Score (TIPS) to classify specimens as MAGE-A4 positive or negative and help identify patients for MAGE-A4–directed treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Synovial sarcomaMelanoma-associated antigen 4 (MAGE-A4)MAGE-A4 protein overexpressionTECELRA

IVD Manufacturer

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 forMAGE-A4 IHC 1F9 pharmDx 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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