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FDA-approved companion diagnostic

therascreen KRAS RGQ PCR Kit

Real-time PCR assay on the Rotor-Gene Q that qualitatively detects KRAS exon 2 codon 12 and 13 mutations in FFPE colorectal tumors to support treatment decisions.

IVD-developed CDxMethod: PCRSpecimen: Tissue (FFPE)Biomarker: KRAS mutation status
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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
P110030
Supplements
Manufacturer
Qiagen Manchester, Ltd. (Qiagen)
Approval date
July 6, 2012
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 therascreen KRAS RGQ PCR Kit 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. Used on the Rotor-Gene Q instrument, 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)KRASG12A, G12D, G12R, G12C, G12S, G12V, G13DERBITUX, VECTIBIX
G12CKRAZATI + ERBITUX, LUMAKRAS + VECTIBIX
KRAS wild-type (absence of mutations in codons 12 and 13)ERBITUX
Non-Small Cell Lung Cancer (NSCLC)KRASG12CKRAZATI, LUMAKRAS

IVD Manufacturer

Qiagen Manchester, Ltd. (Qiagen)

QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of September 30, 2025, QIAGEN employed approximately 5,700 people across more than 35 locations. For more information, visit www.qiagen.com.

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If your organization is connected to Casandra, you can place an electronic order fortherascreen KRAS RGQ PCR Kit 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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