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FDA-approved companion diagnostic

therascreen EGFR RGQ PCR Kit

Real-time PCR assay on the Rotor-Gene Q that qualitatively detects selected EGFR exon 18–21 mutations in FFPE NSCLC tissue to support targeted treatment decisions.

IVD-developed CDxMethod: PCRSpecimen: Tissue (FFPE)Biomarker: EGFR 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
P120022
Supplements
S001, S016, S018
Manufacturer
Qiagen Manchester, Ltd. (Qiagen)
Approval date
July 12, 2013
Test specifications
Methodology
PCR
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
EGFR mutation status
What this test is

The therascreen EGFR RGQ PCR Kit is an in vitro diagnostic, allele-specific real-time PCR assay that qualitatively detects defined EGFR mutations in exons 18, 19, 20, and 21 in DNA from formalin-fixed, paraffin-embedded non–small cell lung cancer tissue. Used on the Rotor-Gene Q instrument, it reports mutation detected or not detected to establish EGFR mutation status and guide EGFR-targeted treatment planning.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Non-Small Cell Lung Cancer (NSCLC)EGFR (HER1)Exon 19 deletion or exon 21 L858R substitution mutationGILOTRIF, IRESSA, VIZIMPRO
L861Q, G719X and S7681GILOTRIF

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.

Order this test

If your organization is connected to Casandra, you can place an electronic order fortherascreen EGFR 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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