The FAKTION trial was designed in 2012, and had defined PI3K/AKT/PTEN pathway-altered status in terms of whether tumours carried one of four specific PIK3CA mutations (E542K or E545K in exon 9 or H1047R or H1047L in exon 20 detected by either pyrosequencing or digital-droplet PCR [ddPCR] tests (or both) on tumour tissue or cell-free DNA [cfDNA]), or displayed loss of PTEN expression by immunohistochemistry. This evidence concerns the gene PIK3CA and neoplasm.