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FDA-approved companion diagnostic

cobas 4800 BRAF V600 Mutation Test

Real-time PCR assay on the cobas 4800 System that qualitatively detects BRAF V600 mutations in FFPE tumor tissue to support targeted treatment decisions.

IVD-developed CDxMethod: PCRSpecimen: Tissue (FFPE)Biomarker: BRAF V600 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
P110020
Supplements
S016
Manufacturer
Roche Molecular Systems, Inc. (Roche Diagnostics)
Approval date
August 17, 2011
Test specifications
Methodology
PCR
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
BRAF V600 mutation status
What this test is

The cobas 4800 BRAF V600 Mutation Test is an in vitro diagnostic, real-time PCR assay that qualitatively detects BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded tumor tissue. Run on the cobas 4800 System, it reports mutation detected or not detected to establish BRAF mutation status and help guide use of BRAF-directed treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
MelanomaBRAFV600EZELBORAF
V600E or V600KCOTELLIC + ZELBORAF

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 4800 BRAF V600 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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