Roche’s Breast Cancer Test for PIK3CA Mutation Gains CE Mark

Roche has received CE mark certification for its cobas PIK3CA Mutation Test, an in vitro diagnostic (IVD) that can detect a mutation in patients with advanced or metastatic breast cancer.

PIK3CA is the most commonly mutated gene in advanced or metastatic breast cancer and the mutations are associated with resistance to endocrine treatment, tumor growth and a poor overall prognosis.

The diagnostic test can detect 17 mutations in a breast cancer patient’s PIK3CA gene and can be used by clinicians to identify patients who are most likely to benefit from the approved phosphoinositide 3-kinase targeted therapy.

The test can process up to 30 samples per run on Roche’s cobas z 480 analyzer system and can deliver results in under eight hours.