F1CDx has also demonstrated clinical validity for identifying EGFR exon 19 deletions, EGFR L858R and T790M mutated, ALK-rearranged or BRAF V600E-mutated tumors in NSCLC, ERBB2 (HER2) amplifications in breast cancers, absence of KRAS mutations in CRC, and BRAF V600 mutations in melanoma demonstrating equivalent clinical utility to other validated assay in pivotal therapeutic trials. The gene discussed is ERBB2; the disease is breast carcinoma.