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FDA-approved companion diagnostic

cobas KRAS Mutation Test

Real-time PCR assay on the cobas 4800 System that qualitatively detects KRAS codon 12/13 mutations in FFPE colorectal tumors to support treatment decisions.

IVD-developed CDxMethod: PCRSpecimen: Tissue (FFPE)Biomarker: KRAS mutation status
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About this test

FDA approval details
PMA number
P140023
Supplements
Manufacturer
Roche Molecular Systems, Inc. (Roche Diagnostics)
Approval date
May 7, 2015
Test specifications
Methodology
PCR
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
KRAS mutation status
What this test is

The cobas KRAS Mutation Test is an in vitro diagnostic, allele-specific real-time PCR assay that qualitatively detects KRAS exon 2 codon 12 and 13 mutations in DNA from formalin-fixed, paraffin-embedded colorectal cancer tissue. Run on the cobas 4800 System, it reports mutation detected or not detected to establish KRAS mutation status and support targeted treatment planning.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Colorectal Cancer (CRC)KRASMutations in codons 12 and 13 of KRAS geneERBITUX, VECTIBIX

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.

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If your organization is connected to Casandra, you can place an electronic order forcobas KRAS 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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