TEST:

therascreen® PIK3CA RGQ PCR Kit

The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative in vitro diagnostic PCR test for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene using a sample of DNA extracted from either formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or K2EDTA anticoagulated blood plasma, taken from a patient with breast cancer. It is intentded to aid in the selection of patients with breast cancer who may be eligible for treatment with the a-selective PI3K-inhibitor, PIQRAY (alpelisib), in combination with the estrogen receptor antagonist, fulvestrant.