First FDA-approved
comprehensive liquid
biopsy with broad
Medicare coverage.2
Actionable results in 7
days to guide treatment
decisions.1*
Minimally invasive—only requires 2 tubes of blood.5
Multiple liquid companion diagnostic (CDx) FDA approvals for NSCLC, now with the only FDA-approved CDx for targeted breast cancer therapy in ESR1 mutations.1,6,7
Identify biomarkers to pair patients with targeted therapies1,6-8
| 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) | |
| Biomarker | Therapy | |
|---|---|---|
| Breast cancer | ||
| Breast cancer | ESR1 missense mutations between codons 310-547 | ORSERDU™ (elacestrant) |
Detect guideline-recommended genomic
biomarkers across all 4 major alteration classes.1
Guardant360 CDx detects actionable biomarkers in 55 FDA-approved, clinically relevant genes.1
| Single Nucleotide Variants (SNVs) | Single Nucleotide Variants (SNVs) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AKT1 | ESR1 | NF1 | ||||||||||
| ALK | FGFR1 | NFE2L2 | ||||||||||
| APC | FGFR2 | NRAS | ||||||||||
| AR | FGFR3 | NTRK1 | ||||||||||
| ARAF | GATA3 | NTRK3 | ||||||||||
| ATM‡ | GNA11 | PDGFRA | ||||||||||
| BRAF | GNAQ | PIK3CA | ||||||||||
| BRCA1§ | HRAS | PTEN | ||||||||||
| BRCA2§ | IDH1 | RAF1 | ||||||||||
| CCND1 | IDH2 | RET | ||||||||||
| CDH1 | KIT | RHEB | ||||||||||
| CDK4 | KRAS | ROS1 | ||||||||||
| CDK6 | MAP2K1 | SMAD4 | ||||||||||
| CDK12‡ | MAP2K2 | SMO | ||||||||||
| CDKN2A | MET | STK11 | ||||||||||
| CTNNB1 | MLH1 | TERT | ||||||||||
| EGFR | MTOR | TSC1 | ||||||||||
| ERBB2 | MYC | VHL | ||||||||||
| AKT1 | BRAF | CDK6 | ESR1 | GNAQ | MAP2K1 | NF1 | PIK3CA | SMAD4 | ||||
| ALK | BRCA1§ | CDK12‡ | FGFR1 | HRAS | MAP2K2 | NFE2L2 | PTEN | SMO | ||||
| APC | BRCA2§ | CDKN2A | FGFR2 | IDH1 | MET | NRAS | RAF1 | STK11 | ||||
| AR | CCND1 | CTNNB1 | FGFR3 | IDH2 | MLH1 | NTRK1 | RET | TERT | ||||
| ARAF | CDH1 | EGFR | GATA3 | KIT | MTOR | NTRK3 | RHEB | TSC1 | ||||
| ATM‡ | CDK4 | ERBB2 | GNA11 | KRAS | MYC | PDGFRA | ROS1 | VHL | ||||
| Insertions and Deletions (Indels) | Insertions and Deletions (Indels) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AKT1 | EGFR | MLH1 | ||||||||||
| ALK | ERBB2 | NF1 | ||||||||||
| APC | ESR1 | PDGFRA | ||||||||||
| ATM‡ | FGFR2 | PIK3CA | ||||||||||
| BRAF | GATA3 | PTEN | ||||||||||
| BRCA1§ | HNF1A | RET | ||||||||||
| BRCA2§ | HRAS | ROS1 | ||||||||||
| CDH1 | KIT | STK11 | ||||||||||
| CDK12‡ | KRAS | TSC1 | ||||||||||
| CDKN2A | MET | VHL | ||||||||||
| AKT1 | ATM ‡ | BRCA2§ | CDKN2A | ESR1 | HNF1A | KRAS | NF1 | PTEN | STK11 | |||
| ALK | BRAF | CDH1 | EGFR | FGFR2 | HRAS | MET | PDGFRA | RET | TSC1 | |||
| APC | BRCA1§ | CDK12‡ | ERBB2 | GATA3 | KIT | MLH1 | PIK3CA | ROS1 | VHL | |||
| Copy Number Amplifications (CNAs) | |
|---|---|
| ERBB2 | MET |
| ERBB2 | MET |
| Fusions | |||
|---|---|---|---|
| ALK | NTRK1 | ||
| RET | ROS1 | ||
| ALK | NTRK1 | RET | ROS1 |
References: 1. Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. July 2021. 2. FDA News Release. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. August 7, 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. Foundation Medicine. FoundationOne®Liquid CDx. Accessed June 29, 2023. https://www.foundationmedicine.com/test/foundationone-liquid-cdx 4. Cleveland Clinic. Liquid Biopsy. August 11, 2022. Accessed June 29, 2023. https://my.clevelandclinic.org/health/diagnostics/23992-liquid-biopsy 5. Guardant360® CDx Instructions for Use. Guardant Health, Inc. Redwood City, CA. August 2022. 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. FDA Recently Approved Devices. Guardant360 CDx – P200010/S008. September 12, 2022. https://www.fda.gov/medical-devices/recently-approved-devices/guardant360-cdx-p200010s008 8. Dean L, Kane M. Trastuzumab Therapy and ERBB2 Genotype. January 5, 2021. Accessed June 29, 2023. https://www.ncbi.nlm.nih.gov/books/NBK310376/#_NBK310376_pubdet 9. TAGRISSO® (osimertinib) Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. October 2022. 10. RYBREVANT™ (amivantamab-vmjw) Prescribing Information. Janssen Biotech, Inc. Horsham, PA. December 2021. 11. ENHERTU® (fam-trastuzumab deruxtecan-nxki) Prescribing Information. Daiichi Sankyo, Inc. Basking Ridge, NJ. August 2022. 12. LUMAKRAS™ (sotorasib) Prescribing Information. Amgen Inc. Thousand Oaks, CA. May 2021. 13. ORSERDU™ (elacestrant) Prescribing Information. Stemline Therapeutics, Inc. New York, NY. January 2023.