longer overall survival
with genomic profiling results in patients with NSCLC.13
Guardant360® CDx—a fast, FDA-approved CGP panel with guideline-recommended biomarkers.1,2
The leading liquid biopsy.2*
Overview
Key features for Guardant360 CDx
First FDA-approved comprehensive liquid biopsy.1,2
Actionable results in 5 days.3†
Only requires 2 tubes of blood.4
Broad commercial and Medicare coverage.
Multiple CDx FDA approvals in NSCLC, including the only FDA-approved CDx for targeted breast cancer therapy with ESR1 mutations.1,5,6
Identify actionable biomarkers to pair patients with targeted therapies.1,5-7
| Indication | Biomarker | Therapy |
|---|---|---|
| Lung cancer | ||
| Lung cancer | EGFR exon 19 deletions, L858R, and T790M | TAGRISSO® (osimertinib)‡ |
| EGFR exon 20 insertions | RYBREVANT® (amivantamab-vmjw) | |
| ERBB2/HER2 activating mutations (SNVs and exon 20 insertions) | ERBB2/HER2 activating mutations (SNVs and exon 20 insertions) | ENHERTU® (fam-trastuzumab deruxtecan-nxki) |
| KRAS G12C | LUMAKRAS™ (sotorasib) | |
Chart is adapted from the Guardant360® CDx Technical Information.
Biomarker Panel
Identify guideline-recommended biomarkers across all 4 major alteration classes.1
As a professional service, Guardant360 CDx assesses 74 genes.1,8§ Select a tumor type below to explore covered biomarkers.
Guideline-recommended biomarkers covered9:
ALKBRAFEGFRERBB2KRASMETNTRK1RETROS1
Single Nucleotide Variants (SNVs) and Insertions and Deletions (Indels) (74 genes)
Copy Number Amplifications (18 genes)
Fusions (6 genes)
MSI Status
Qualitative result
Guideline-recommended biomarkers covered10:
AKT1BRCA1BRCA2ERBB2ESR1NTRK1PIK3CAPTENRETMSI
Single Nucleotide Variants (SNVs) and Insertions and Deletions (Indels) (74 genes)
Copy Number Amplifications (18 genes)
Fusions (6 genes)
MSI Status
Qualitative result
Guideline-recommended biomarkers covered11:
BRAFERBB2KRASNRASNTRK1RETMSI
Single Nucleotide Variants (SNVs) and Insertions and Deletions (Indels) (74 genes)
Copy Number Amplifications (18 genes)
Fusions (6 genes)
MSI Status
Qualitative result
Guideline-recommended biomarkers covered12:
ATMBRCA1BRCA2CDK12MLH1PTENRB1TP53MSI
Single Nucleotide Variants (SNVs) and Insertions and Deletions (Indels) (74 genes)
Copy Number Amplifications (18 genes)
Fusions (6 genes)
MSI Status
Qualitative result
Concurrent
liquid and tissue testing finds more actionable biomarkers in less time.14
Guardant360 tests are covered across 300 million lives with all major insurers, including Aetna, Anthem, Cigna, United Healthcare, and others.
*Based on Guardant Health data on file brand tracker data.
†Median turnaround time from sample receipt to results.
‡The efficacy of TAGRISSO® (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative, or unknown population, and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.
§Not reviewed or approved by the FDA.
||For these genes, alterations reported may include germline (inherited) alterations but not somatic (not inherited) alterations. The assay filters germline variants from reporting except for pathogenic BRCA1, BRCA2, ATM, and CDK12 alterations. However, if a reported alteration is suspected to be germline, confirmatory testing should be considered in the appropriate clinical context. The test is not intended to replace germline testing or to provide information about cancer predisposition.
¶For these genes, alterations reported may include somatic (not inherited) alterations or germline (inherited) alterations. The assay filters germline variants from reporting except for pathogenic BRCA1, BRCA2, ATM, and CDK12 alterations. However, if a reported alteration is suspected to be germline, confirmatory testing should be considered in the appropriate clinical context. The test is not intended to replace germline testing or to provide information about cancer predisposition. Gene charts are adapted from the Guardant360® CDx Technical Information.
References: 1. Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. February 2023. 2. FDA News Release. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. August 7, 2020. Updated August 11, 2020. Accessed June 29, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test 3. Guardant Health data on file. September 27, 2024. Guardant Health, Inc. Redwood City, CA. 4. Guardant360® CDx Instructions for Use. Guardant Health, Inc. Redwood City, CA. August 2022. 5. FDA Recently Approved Devices. Guardant360 CDx — P200010/S008. September 12, 2022. Accessed December 18, 2023. https://www.fda.gov/medical-devices/recently-approved-devices/guardant360-cdx-p200010s008 6. FDA Recently Approved Drugs. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. January 27, 2023. Accessed June 29, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer 7. Dean L, Kane M. Trastuzumab therapy and ERBB2 genotype. In: Pratt VM, Scott SA, Pirmohamed M, Esquivel B, Kattman BL, Malheiro AJ, eds. Medical Genetics Summaries. Bethesda MD: National Center for Biotechnology Information (US); August 5, 2015. 8. Guardant360® Assay Specifications. 2019. Guardant Health, Inc. Redwood City, CA. 9. Riely GJ, Wood DE, Ettinger DS, et al. NCCN Guidelines® Insights: Non-Small Cell Lung Cancer, Version 5.2024, NCCN clinical practice guidelines in oncology. Accessed June 1, 2024. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf 10. Gradishar WJ, Moran MS, Abraham J, et al. NCCN Guidelines® Insights: Breast Cancer, Version 2.2024, NCCN clinical practice guidelines in oncology. Accessed June 1, 2024. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf 11. Benson AB, Venook AP, Adam M, et al. NCCN Guidelines® Insights: Colon Cancer, Version 3.2024, NCCN clinical practice guidelines in oncology. Accessed June 1, 2024. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf 12. Schaeffer EM, Srinivas S, Adra N, et al. NCCN Guidelines® Insights: Prostate Cancer, Version 4.2024, NCCN clinical practice guidelines in oncology. Accessed June 1, 2024. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf 13. Aggarwal C, Marmarelis ME, Hwang WT, et al. Association between availability of molecular genotyping results and overall survival in patients with advanced nonsquamous non–small-cell lung cancer. JCO Precis Oncol. 2023;7:e2300191. doi:10.1200/PO.23.00191 14. 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