How a New Genomic Test Could Change Cancer Care

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx™, the company’s comprehensive companion diagnostic test for solid tumors. FoundationOne CDx is intended for use by health care professionals to help inform cancer treatment management in accordance with professional guidelines for patients with solid tumors. The first and only FDA-approved test of its kind for all solid tumors, FoundationOne CDx is a diagnostic test that acts as: “Access to important genomic information is a critical step in being able to offer innovative and targeted treatment options.” Tweet this a comprehensive companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies; a comprehensive genomic profiling (CGP) test that includes genomic biomarkers to help inform the use of other targeted oncology therapies, including immunotherapies; a tool for physicians that identifies patient opportunities for clinical trial participation; and, an FDA-approved platform for companion diagnostic development for biopharma companies developing precision therapeutics. FoundationOne CDx assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It is also indicated as a companion diagnostic for patients with certain types of non-small...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Source Type: news