References

Based on ctDNA test share from the MRD in early-stage cancer patient chart audit. Guardant Health data on file. April 2026.

cDNA: circulating tumor DNA; MRD: minimal or molecular residual disease.
*Limit of detection is specific to tumor fraction at which the test has a >95% probability of detection at 3-4ng DNA input. Limit of detection of 0.005% applies specifically to CRC MRD
†Median turnaround time from sample receipt to results.
‡Initiation of follow up molecular profiling with Guardant360 Liquid CDx in MRD requires that no Guardant liquid therapy selection test has been performed within the prior 45 days and that other program criteria are met: stage I-Ill surveillance with a positive Guardant Reveal MRD result, tumor fraction (TF) ≥0.05%, and other predefined performance thresholds. Threshold to initiate testing for Therapy Response Monitoring refers to a ~50% increase in tumor fraction between 2 consecutive time points AND a TF of 0.1% on the most recent draw AND the patient has not had a Guardant360 CDx or Guardant360 Liquid CDx test in the past 45 days.

Important note: Guardant Reveal was developed as a Laboratory Developed Test (LDT), 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. This test has not been reviewed or approved by the US FDA. 
Guardant Reveal Assay Specifications. Guardant Health, Inc; 2025

The #1 tissue free test for ctDNA monitoring1