Laboratory Developed Test

Important note: Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 were developed as Laboratory Developed Tests (LDTs), 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. These tests have not been cleared or approved by the US FDA.