TESTING PARADIGM
Capture more guideline-recommended actionable biomarkers and cut time to treatment by ordering liquid and tissue CGP testing at the same time.1,2*
Concurrent liquid and tissue CGP testing saves time.1,2†‡§
SWIPE TO REVEAL FULL TABLE
Testing paradigms are for illustrative purposes only.
*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.
‡Data shown for only the Tier 1 variants assessed in the Cui et al study. A Tier 1 variant is defined as an actionable biomarker with the most substantial clinical significance, including those related to FDA-approved treatments, proposed by professional guidelines, and/or with a strong consensus of predictive value.
§Data shown for targetable alterations assessed in the study.
IILiquid and tissue testing may be initiated at the same time, but sample processing does not occur concurrently.
¶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.3 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.
References: 1. Page RD, Drusbosky LM, Dada H, et al. Clinical outcomes for plasma-based comprehensive genomic profiling versus standard-of-care tissue testing in advanced non-small cell lung cancer. Clin Lung Cancer. 2022;23(1):72-81. doi:10.1016/j.cllc.2021.10.001 2. Cui W, Milner-Watts C, O’Sullivan H, et al. Up-front cell-free DNA next generation sequencing improves target identification in UK first line advanced non-small cell lung cancer (NSCLC) patients. Eur J Cancer. 2022;171:44-54. doi:10.1016/j.ejca.2022.05.012 3. Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. July 2021. 4. Guardant360 TissueNext™ Assay Specifications. Guardant Health, Inc. Redwood City, CA.