Foundation Medicine has demonstrated direct clinical validity and clinical utility for F1CDx in a pan-tumor setting for TMB-H status and NTRK fusions, and for MET exon 14 skipping in NSCLC, PIK3CA mutations in breast cancers, BRCA1/2 alterations in ovarian cancer, HRRm in prostate cancer, and FGFR fusions and rearrangements in cholangiocarcinoma. This evidence concerns the gene BRCA1 and breast cancer.