FDA Approves cobas EGFR Mutation Test v2 as Companion Diagnostic With Gefitinib in First-Line Treatment of NSCLC

August 29, 2018 – The U.S. Food and Drug Administration (FDA) recently approved the cobas EGFR Mutation Test v2 as a companion diagnostic test with gefitinib for the first-line treatment of patients with non–small cell lung cancer (NSCLC). A companion diagnostic test provides information that is essential for the safe and effective use of a corresponding therapeutic product. Clinical studies have demonstrated that patients diagnosed with NSCLC who test positive for … (leggi tutto)