Roche has launched a diagnostic genetic test to detect mutations in the PIK3CA gene in patients with advanced or metastatic breast cancer in the European Union.

The cobas PIK3CA mutation test, performed in the lab (in vitro) and previously available for research purposes only, is now available in countries accepting the CE mark.

“We are pleased to offer the cobas PIK3CA Mutation Test […], enabling clinicians to accurately and quickly manage their breast cancer patients,” Thomas Schinecker, PhD, CEO of Roche Diagnostics, said in a press release.

Approximately 40% of patients with advanced or metastatic breast cancer have a mutation in the PIK3CA gene. Mutations in this gene boost the activity of molecular pathways that drive cellular proliferation, causing tumor growth and progression. Moreover, these patients are more likely to be resistant to hormone treatment and have a poor overall prognosis.

“Nearly two million women are diagnosed with breast cancer each year, and an estimated half a million could harbour a PIK3CA mutation. If correctly identified, some of these women may benefit from targeted therapy,” added Schinecker.

The new test allows for the qualitative detection and identification of 17 mutations in the PIK3CA gene in DNA isolated from a patient’s tumor tissue samples to identify those with advanced or metastatic breast cancer whose tumors present these mutations.

This diagnostic tool can help clinicians identify patients most likely to benefit from approved targeted therapy with phosphoinositide 3-kinase inhibitors.

It’s based on real-time polymerase chain reaction, a type of DNA amplification technique, and offers high sensitivity, repeatability, and clinical reproducibility. Automated results can be reported in under eight hours, and each test run can include up to 30 samples.

Of note, CE Mark approval is a seal of approval issued by the European Commission that means products have been assessed to meet pre-established safety, health, and environmental protection requirements. CE Marking also supports fair competition by holding all companies accountable to the same rules.