Roche launches cobas PIK3CA Mutation Test for patients with advanced or metastatic breast cancer in countries accepting the CE mark

Basel, 15 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas ® PIK3CA Mutation Test for patients with advanced or metastatic breast cancer. Previously only available as research use only (RUO), this in vitro diagnostic (IVD) test is now available in countries accepting the CE mark.“Nearly two million women are diagnosed with breast cancer each year, and an estimated half a million could harbour a PIK3CA mutation.3,4 If correctly identified, some of these women may benefit from targeted therapy, ” said Thomas Schinecker, CEO Roche Diagnostics. “We are pleased to offer the cobas PIK3CA Mutation Test CE-IVD, enabling clinicians to accurately and quickly manage their breast cancer patients.” In advanced or metastatic breast cancer, PIK3CA mutations are associated with tumour growth, resistance to endocrine treatment, and a poor overall prognosis. The cobas PIK3CA Mutation Test detects 17 mutations in the PIK3CA gene and can help clinicians identify patients who may benefit from phosphoinositide 3-kinase (PI3K) targeted therapy as supported by medical guidelines.5,6About the cobas PIK3CA Mutation Test The cobas PIK3CA Mutation Test is a real-time PCR test 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 isolated from formalin-fixed paraffin-embedded tissue (FFPET). The cobas PIK3CA Mutation Test is intended to identify patients w...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news