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therascreen® PDGFRA RGQ PCR Kit

The QIAGEN therascreen® PDGFRA RGQ PCR Kit is a realtime 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) patient’s 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.

Details

Device typeGastrointestinal cancer genotyping IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict gastrointestinal cancer [e.g., gastrointestinal stromal tumour (GIST)] based on multiple disease-associated genotypes, which may include KIT and PDGFRA gene mutations, using a nucleic acid technique (NAT).

FDA categorySomatic Gene Mutation Detection System

Device ID04053228034834

Catalog number874921

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone800-362-7737

Emailtechservice-na@qiagen.com

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