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FDA-approved companion diagnostic

cobas EZH2 Mutation Test

Real-time PCR assay on the cobas platform that qualitatively detects selected EZH2 mutations in FFPE follicular lymphoma tissue to support targeted treatment decisions.

IVD-developed CDxMethod: PCRSpecimen: Tissue (FFPE)Biomarker: EZH2 mutation status
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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
P200014
Supplements
Manufacturer
Roche Molecular Systems, Inc. (Roche Diagnostics)
Approval date
June 18, 2020
Test specifications
Methodology
PCR
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
EZH2 mutation status
What this test is

The cobas EZH2 Mutation Test is an in vitro diagnostic, allele-specific real-time PCR assay that qualitatively detects selected activating EZH2 mutations in DNA from formalin-fixed, paraffin-embedded follicular lymphoma tissue. Run on a cobas real-time PCR system, it reports mutation detected or not detected to establish EZH2 mutation status and help guide use of EZH2-directed treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Follicular Lymphoma TumorEZH2Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the EZH2 geneTAZVERIK

IVD Manufacturer

Roche Molecular Systems, Inc. (Roche Diagnostics)

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

Order this test

If your organization is connected to Casandra, you can place an electronic order forcobas EZH2 Mutation Test 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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