Roche, Basel, Switzerland, launched 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 2 million women are diagnosed with breast cancer each year, and an estimated half a million could harbor a PIK3CA mutation. If correctly identified, some of these women may benefit from targeted therapy,” says Thomas Schinecker, CEO of 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 tumor 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.

For more information, visit Roche.