The PDGFRA companion diagnostic assay is a real-time qualitative PCR in vitro diagnostic assay detects the D842V somatic mutation in the PDGFRA gene to determine which patients may be a candidate for treatment with AYVAKIT. The therascreen PDGFRA kit uses genomic DNA extracted from a patient’s formalin-fixed paraffin-embedded (FFPE) tumor tissue. FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for sample preparation and the Rotor-Gene Q (RGQ) MDx instrument for DNA amplification and mutation detection.