This test was evaluated and its performance characteristics determined by Exosome Diagnostics, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. Exosome Diagnostics is certified under the Clinical Laboratory Improvement Amendments (CLIA) Act of 1988 as qualified to perform high complexity clinical testing. CLIA number – 22D2093470
Exosome Diagnostics and ExoDx, are registered and unregistered trademarks of Exosome Diagnostics, Inc.