Important Note: The Guardant360 Response and Guardant360 tests were developed, and their performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. Guardant360 Response refers to Guardant360 Response Laboratory Developed Test (LDT) and Guardant360 refers to the Guardant360 LDT. These tests have not been cleared or approved by the US FDA. Guardant360 CDx is not approved by the US FDA to assess treatment response or long-term survival.