Regarding PIK3CA alterations in breast cancer, KRAS/NRAS wild-type status in advanced CRC, BRAFV600E mutations in CRC, BRAFV600E or BRAFV600K mutations in melanoma, EGFR exon19 deletions and L858R mutations in NSCLC, and MSI status in endometrial carcinoma and solid tumors, positive percent agreement (PPA) and negative percent agreement (NPA) ranged from 97–100%, and all upper limits of the 95% confidence intervals met pre-specified non-inferiority margins, as described in ‘Methods’. This evidence concerns the gene PIK3CA and breast carcinoma.