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QIAGEN receives FDA approval for companion diagnostic to Blueprint Medicines’ AYVAKIT (avapritinib) in gastrointestinal stromal tumors (GlobeNewswire)
"QIAGEN...announced the U.S. Food and Drug Administration (FDA) approval of its therascreen PDGFRA RGQ PCR kit (therascreen PDGFRA kit). This companion diagnostic is intended for use to aid clinicians in identifying patients with gastrointestinal stromal tumors (GIST) who may be eligible for treatment with AYVAKIT® (avapritinib), which is approved in the U.S. for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. The kit is the first platelet-derived growth factor receptor alpha (PDGFRA) assay to receive FDA approval as a companion diagnostic."
FDA event
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therascreen PDGFRA RGQ PCR kit
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Ayvakit (avapritinib)