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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 Molecular Genetics
Clinical TrialsNCT02508532
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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
LabelingLabeling
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