The U.S. Food and Drug Administration (FDA) has granted premarket approval for Thermo Fisher’s Oncomine Dx Target Test as a companion diagnostic (CDx) developed to help identify non-small cell lung cancer (NSCLC) patients. Lung cancer is the leading cause of cancer deaths worldwide and CDx targets epidermal growth factor receptor (EGFR), an important therapeutic biomarker for NSCLC. The test is the first and only FDA-approved next-generation sequencing (NGS) CDx for determining RYBREVANT treatment eligibility in patients whose disease has progressed on or after platinum-based chemotherapy. The test is the only globally distributable NGS CDx solution approved and reimbursed by government and commercial insurers in more than 15 countries, including the U.S., multiple European nations, Japan, South Korea, and the Middle East, affecting potentially more than 550 million lives worldwide. As a leading biomedical company, Thermo Fisher Scientific Inc. is committed to accelerating life sciences research, solving complex analytical challenges, increasing productivity in laboratories, and improving patient outcomes through diagnostics and the development and manufacturing of life-changing therapies.
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