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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Devicetherascreen PDGFRA RGQ PCR Kit
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
QIAGEN Strasse 1
Hilden 40724
PMA NumberP210002
Date Received01/29/2021
Decision Date06/29/2023
Product Code OWD 
Docket Number 23M-3451
Notice Date 08/18/2023
Advisory Committee
Clinical TrialsNCT02508532
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the therascreen PDGFRA RGQ PCR Kit. The QIAGEN therascreen® PDGFRA RGQ PCR Kit is a real-time qualitative in vitro diagnostic assay for the detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from Gastrointestinal Stromal Tumor (GIST) patients formalin-fixed paraffin-embedded (FFPE) tumor tissue. The therascreen PDGFRA RGQ PCR Kit is intended for use as a companion diagnostic test, to aid clinicians in identification of patients with GIST who may be eligible for treatment with AYVAKIT (avapritinib) based on a PDGFRA mutation detected result. FFPE tumor specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene® Q (RGQ) MDx instrument for automated amplification and detection. The therascreen PDGFRA RGQ PCR Kit is to be used by trained personnel in a professional laboratory environment.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness