Company Profile
Guardant Health, Inc. is a US-based precision oncology company and liquid biopsy test manufacturer, headquartered in Palo Alto, California, USA. Founded in 2012 by Helmy Eltoukhy and AmirAli Talasaz, the company operates as a publicly listed entity on the Nasdaq Stock Exchange (GH) with approximately 2,000+ employees, serving global oncology and cancer screening markets through advanced blood-based diagnostics and AI analytics.
Core Products ＆ Technologies
Precision Oncology ＆ Liquid Biopsy
• Guardant360 CDx: FDA-approved comprehensive liquid biopsy test for tumor mutation profiling and companion diagnostics in advanced cancer; first CDx approval in colorectal cancer received in 2025
• Guardant360 TissueNext: Tissue-based genomic profiling test for solid tumor biomarker detection
• Guardant360 TissueNow: Rapid tissue-based test delivering results within days for urgent treatment decisions
• Guardant Reveal: Tissue-free liquid biopsy for early-stage cancer recurrence monitoring and late-stage therapy response assessment
Cancer Screening
• Shield™ CRC Blood Test: FDA-approved blood test for primary colorectal cancer screening in average-risk adults aged 45+; first blood-based CRC screening test approved by FDA (July 2024); CMS ADLT status with Medicare reimbursement at $1,495 per test
• Shield™ MCD (Multi-Cancer Detection): Blood-based test for early detection of multiple solid tumors including bladder, esophageal, gastric, liver, lung, ovarian, and pancreatic cancers; FDA Breakthrough Device Designation (June 2025)
Biopharma ＆ AI Platform
• Guardant Infinity Smart Platform: AI-powered clinico-genomic data platform leveraging 1,000,000+ patient samples and 400,000+ epigenetic profiles for companion diagnostic development
• Biopharma Services: Clinical trial assay development, real-world data generation, and regulatory support for oncology drug development
Market Position ＆ Certifications
Guardant Health holds a global leadership position in the liquid biopsy and blood-based cancer screening market, competing with Exact Sciences (Cologuard) and Foundation Medicine (Roche). Key strengths include:
• 14 years of US precision oncology innovation heritage since founding
• Regulatory firsts: First FDA-approved blood test for primary CRC screening; first Guardant360 CDx approval in colorectal cancer; FDA Breakthrough Device Designation for Shield MCD
• Clinical validation: Shield CRC demonstrated 83% sensitivity and 90% specificity in the ECLIPSE pivotal study published in NEJM
• Commercial scale: 2025 revenue reached $982 million (+33% YoY); 276,000+ oncology tests and 87,000+ Shield screening tests performed
• Reimbursement momentum: Shield covered by Medicare, TRICARE, and expanding private payer networks
Corporate Timeline
2012 — Founded in Palo Alto, California, USA
2018 — Completed initial public offering on Nasdaq (GH)
2020 — Guardant360 CDx received FDA approval for comprehensive liquid biopsy
2021 — Launched Guardant Reveal for early-stage cancer recurrence monitoring
2024 — Shield became the first FDA-approved blood test for primary CRC screening (July); launched Guardant360 TissueNext and TissueNow
2025 — Shield received CMS ADLT status and Medicare coverage (March); Guardant360 CDx received first colorectal cancer companion diagnostic approval; acquired MetaSight Diagnostics for multi-cancer detection (December); full-year revenue reached $982 million
2026 — Established strategic collaboration with Merck for companion diagnostics; launched community CRC screening grant program; 2026 revenue guidance set at $1.25–$1.28 billion (+27–30%)
Target Markets ＆ Applications
• Advanced Cancer Treatment Selection: Guardant360 CDx for comprehensive genomic profiling and companion diagnostic-guided therapy selection in metastatic solid tumors
• Early-Stage Cancer Monitoring: Guardant Reveal for recurrence monitoring in early-stage colorectal, breast, and lung cancer
• Colorectal Cancer Screening: Shield blood test for average-risk adults aged 45+ as a non-invasive alternative to colonoscopy
• Multi-Cancer Early Detection: Shield MCD for screening of multiple solid tumor types in asymptomatic adults
• Oncology Drug Development: Biopharma services and Infinity platform for clinical trial design and companion diagnostic co-development
Contact Information
Global Headquarters
Address: 3100 Hanover Street, Palo Alto, CA 94304, USA
Telephone: (855) 698-8887
Website: guardanthealth.com
Corporate Status
Entity Type: Publicly Listed Company (No Parent Company)
Stock: Nasdaq: GH
Investor Relations: investors.guardanthealth.com
