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FDA-approved companion diagnostic

therascreen FGFR RGQ RT-PCR Kit

Real-time RT-PCR assay on the Rotor-Gene Q that qualitatively detects selected FGFR2/3 mutations and fusions in FFPE urothelial tumors to support targeted therapy decisions.

IVD-developed CDxMethod: PCRSpecimen: Tissue (FFPE)Biomarker: FGFR2/3 alteration 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
P180043
Supplements
Manufacturer
Qiagen Manchester, Ltd. (Qiagen)
Approval date
April 12, 2019
Test specifications
Methodology
PCR
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
FGFR2/3 alteration status
What this test is

The therascreen FGFR RGQ RT-PCR Kit is an in vitro diagnostic, real-time RT-PCR assay that qualitatively detects selected FGFR2 and FGFR3 mutations and fusions in DNA or RNA from formalin-fixed, paraffin-embedded urothelial carcinoma tissue. Run on the Rotor-Gene Q, it reports FGFR alteration detected or not detected to establish FGFR status and help guide FGFR-targeted treatment planning.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Urothelial CancerFGFR3Exon 7: R248C (c.742C>T), S249C (c.746C>G); exon 10: G370C (c.1108G>T) and Y373C (c.1118A>G); and fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3)BALVERSA

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 FGFR RGQ RT-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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