EUAA
CGP = comprehensive genomic profiling
MAF = mutant allele fraction
For the complete intended use statement including companion diagnostic indications, please see the Guardant360 CDx Technical Information: Guardant360CDx.com/technicalinfo.
Product availability may vary depending on region.
Home Oncology Portfolio Partnerships European Policy
References:
*Fast average turnaround time from sample receipt to results is based on stated average turnaround times from Integra Connect data. Comparisons are against other FDA-approved liquid CGP tests as of April 2024.
1. Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. February 2023.
2. Guardant360® CDx Assay Specifications. Guardant Health, Inc. Redwood City, CA.
3. Sehayek, Liquid First is Solid in Naive Non Small Cell Lung Cancer patients: Faster turnaround time with high concordance to solid Next Generation Sequencing, Frontiers in Oncology, 2022.
4. Palmero, Biomarker Discovery and Outcomes for Comprehensive Cell-Free Circulating Tumor DNA Versus Standard-of-Care Tissue Testing in Advanced Non-Small-Cell Lung Cancer, Journal of Clinical Oncology Precision Oncology.
5. https://investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Health-Receives-EU-IVDR-Certification-for-Guardant360-CDx-Liquid-Biopsy-for-Tumor-Mutation-Profiling-Across-All-Solid-Cancers-and-Companion-Diagnostic-Indications/default.aspx
6. PubMed search September 2025.