Testing paradigm Initiating liquid and tissue comprehensive genomic profiling (CGP) simultaneously is the fastest and most efficient testing paradigm.1,2*
Capture a wide range of targetable alterations† 50% faster
than other options.2‡
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*Non-small cell lung cancer patients who are negative from a plasma specimen for EGFR exon 19 deletions, L858R, T790M, EGFR exon 20 insertions, ERBB2/HER2 activating mutations, and KRAS G12C should be reflexed to tissue biopsy testing using an FDA approved tumor tissue test, if feasible.3 Note that “tissue CGP,” known as Guardant360 TissueNext, and “liquid CGP," known as Guardant360, have not been cleared or approved by the FDA. For the complete intended use statement including companion diagnostic indications, please see Guardant360 CDx Technical Information.
†This chart utilizes percent target alterations found by liquid and tissue CGP testing from the European Journal of Cancer Cui et al study. Turnaround time is defined as 7 days for liquid biopsy and 14 days for tissue genotyping. This information is based on Guardant Health data on file.
‡Testing paradigms are for illustrative purposes only.
§Data shown for the targetable alterations assessed in the study.
||Patients who have a negative Guardant360 CDx test result for an indicated companion diagnostic biomarker should be reflexed to tissue biopsy testing using an FDA-approved tumor tissue test, if feasible. Guardant360 TissueNext has not been cleared or approved by the FDA. For the complete intended use statement including companion diagnostic indications for Guardant360 CDx, please see Guardant360 CDx Technical Information.
#Liquid and tissue testing may be initiated at the same time, but sample processing does not occur concurrently.