*=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.
^=When compared to other tissue-free testing companies. Comparisons are based on publicly available information as of October 2025.
1. Guardant Reveal Assay Specifications. 2025. Guardant Health, Inc. Redwood City, CA.; cDNA: circulating tumor DNA; MRD: minimal or molecular residual diseas
Guardant Reveal was developed as Laboratory Developed Tests (LDTs) 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. The test has not been cleared or approved by the US FDA or by EU/UK Notified Body.
Product availability may vary depending on country / region. Guardant Reveal is not approved nor marketed in the EU.