TEST:

cobas® PIK3CA Mutation Test

The cobas® PIK3CA Mutation Test (CE-IVD) is a real-time polymerase chain reaction (PCR) test used to identify patients with advanced or metastatic breast cancer whose tumors harbor phosphoinositide 3-kinase, catalytic, alpha subunit (PIK3CA) mutations. It is intended for the qualitative detection and identification of 17 mutations in exons 2, 5, 8, 10, and 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolation from formalin-fixed paraffin-embedded tumor tissue (FFPET).