ERBB2 and breast carcinoma: For example, the Therascreen® PIK3CA RGQ PCR kit, which received FDA approval for advanced‐stage HR‐positive/HER2 ‐negative breast cancer based on the findings of the phase III SOLAR‐1 trial, is a real‐time PCR test that screens for 11 therapy‐relevant PIK3CA mutations from plasma [69].