Therascreen EGFR RGQ PCR Kit
FDA PMAClass III (US FDA PMA)
by QIAGEN GmbH
Identity
- Trade Name
- THERASCREEN EGFR RGQ PCR KIT FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P120022 FDA PMA
- FDA Product Code
- OWD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Therascreen EGFR RGQ PCR Kit is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPE) nonsmall cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to select patients with NSCLC for whom Gilotrif (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.
Specimens are processed using the QIAAMP DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene Q MDX instrument for automated amplification and detection. The device is approved by the FDA for this specific purpose and has been classified as a Class III Somatic Gene Mutation Detection System.
Frequently asked questions
What mutations does the Therascreen EGFR RGQ PCR Kit detect?
The kit detects exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPE) nonsmall cell lung cancer (NSCLC) tumor tissue. It also detects other mutations including L861Q, G719X, S768I, exon 20 insertions, and T790M, though safety and efficacy of Gilotrif (afatinib) have not been established for these mutations.
How is the Therascreen EGFR RGQ PCR Kit used in patient selection?
The test is intended to be used to select patients with NSCLC for whom Gilotrif (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated. By identifying specific EGFR mutations, the test helps determine which patients may benefit from treatment with this targeted therapy.
What equipment is required to use the Therascreen EGFR RGQ PCR Kit?
The kit requires the QIAAMP DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene Q MDX instrument for automated amplification and detection. These components are necessary for proper processing and analysis of the specimens according to the manufacturer's protocol.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P120022 | Class III | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
Sources (1)
- FDA PMA P120022 24 fields · synced Sep 18, 2026