Covers clinically relevant biomarkers, including TMB, MSI status, and PD-L1.1
MSI, microsatellite instability; PD-L1, programmed death-ligand 1;
TMB, tumor mutation burden.
*Includes TERT promoter region.¹
†Guardant360 TissueNext PD-L1 test powered by Guardant Galaxy is validated for multiple tumor types, including breast, colorectal, gastric, hepatobiliary, lung, pancreatic, prostate, and urothelial cancers. Some cases may require conventional determination of PD-L1 status without AI.1-3
Important note: Guardant360 TissueNext and Guardant Galaxy PD-L1 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.