FDA Approves Foundation Medicine's FoundationOne CDx Diagnostic Test for Solid Tumors

Foundation Medicine, Inc. FMI 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:

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.