After being only available in drug trials, Roche is now commercially launching its new cobas test for PIK3CA breast cancer.
This genetic test seeks out mutations in the PIK3CA gene, changes that can cause cells to grow uncontrollably, which may lead to cancer and is, according to the Swiss giant, the most commonly mutated gene in advanced or metastatic breast cancer, with nearly 40% of patients harboring a mutation in this gene.
The cobas PIK3CA Mutation Test works as a PCR-based test that detects PIK3CA mutations in patients with metastatic breast cancer to help identify those most likely to benefit from Novartis’ Piqray (alpelisib).
That drug was approved last May, coming with its own test, the therascreen PIK3CA RGQ PCR Kit, to detect the PIK3CA mutation in a tissue and/or a liquid biopsy. Roche now adds its cobas as a new diagnostic option.
“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,” said Thomas Schinecker, Ph.D., CEO of Roche Diagnostics.
Roche say its test allows “fast time-to-results” in less than eight hours.