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FDA-approved companion diagnostic

MMR IHC Panel pharmDx

Qualitative IHC panel that assesses MLH1, PMS2, MSH2, and MSH6 expression in FFPE colorectal cancer tissue to determine mismatch repair (MMR) status for immunotherapy planning.

IVD-developed CDxMethod: IHCSpecimen: Tissue (FFPE)Biomarker: dMMR (mismatch repair deficiency)
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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
P250004
Supplements
Manufacturer
Dako Omnis (Agilent Technologies, Inc.)
Approval date
August 15, 2025
Test specifications
Methodology
IHC
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
dMMR (mismatch repair deficiency)
What this test is

MMR IHC Panel pharmDx is an FDA-approved, qualitative immunohistochemical assay performed on the Dako Omnis platform to assess MLH1, PMS2, MSH2, and MSH6 protein expression in FFPE colorectal cancer tissue. By determining mismatch repair–deficient (dMMR) status based on loss of nuclear staining, it helps identify patients who may be candidates for immunotherapy.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Colorectal Cancer (CRC)deficient mismatch repair (dMMR) proteinsMLH1, PMS2, MSH2 and MSH6OPDIVO, OPDIVO + YERVOY

IVD Manufacturer

Dako Omnis (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 forMMR IHC Panel 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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