Important Note: The Guardant360 TissueNext test was developed, and its 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 TissueNext refers to Guardant360 TissueNext Laboratory Developed Test (LDT). This test has not been cleared or approved by the US FDA.

*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.⁴ Note that “tissue CGP,” known as Guardant360 TissueNext, and “liquid CGP test," 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.

^†Includes TERT promoter region.

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download the Gene Pocket Guide Reference List.