FDA approves Roche diagnostic for gene mutation in lung cancer

(Reuters) – U.S. health regulators on Tuesday approved a test developed by Roche for a specific gene mutation present in about 10 percent of non-small cell lung cancers, and said the company's drug Tarceva could be used as an initial treatment in patients with the mutation whose cancer has spread beyond the lungs. This marks the first companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations to be approved by the U.S. Food and Drug Administration, the agency said. The diagnostic is called the Cobas EGFR Mutation Test. …