PIK3CA and breast carcinoma: Currently, only a small number of diagnostic tests using cfDNA are approved by the U.S. Food and Drug Administration, for example, the cobas® EGFR Mutation PCR Test v2 for non-small cell lung cancer [239], a test for ctDNA for PIK3CA mutated hormone receptor positive breast cancer [240], and the SEPT9 methylated DNA test for colorectal cancer [241].