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Roche Nabs CE Mark for PIK3CA Test for Breast Cancer

NEW YORK – Roche announced Tuesday it has received CE marking for its Cobas PIK3CA Mutation test for identifying patients with metastatic breast cancer who might benefit the most from phosphoinositide 3-kinase (PI3K) targeted therapy. 

The test detects 17 mutations in exons 2, 5, 8, 10, and 21 in the PIK3CA gene in DNA isolated from formalin-fixed, paraffin-embedded tissue. Mutations in the PIK3CA gene are associated with tumor growth, resistance to endocrine treatment, and a "poor overall prognosis," Roche said in a statement, adding the test is for use in patients with advanced or metastatic breast cancer. 

The PCR test runs on the Cobas Z 480 analyzer and can process up to 30 samples per run, providing results in less than eight hours. The test was previously available for research use only.

The PIK3CA gene is the most commonly mutated gene in advanced or metastatic breast cancer, Roche said, with nearly 40 percent of patients having a mutation in the gene.