Company Description
Guardant Health, Inc. (Nasdaq: GH) is a precision oncology company that focuses on "guarding wellness" and giving people more time free from cancer. Founded in 2012 and based in Palo Alto, California, Guardant Health states that it is transforming patient care and accelerating new cancer therapies by providing insights into what drives disease through advanced blood and tissue tests, real-world data and AI analytics. According to the company’s descriptions in multiple press releases, Guardant tests are used across the cancer care continuum, from early detection and screening to monitoring and treatment selection for advanced disease.
Guardant Health’s business centers on liquid biopsy and other oncology diagnostics. The company offers blood-based tests that analyze circulating tumor DNA (ctDNA) and other signals in the blood, as well as tissue-based tests, to help clinicians understand tumor biology and guide decisions. Guardant states that its tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer.
Core products and test platforms
Based on the company’s own disclosures, Guardant Health has developed several branded tests and platforms:
- Guardant360 LDT – described in Polygon data as a liquid biopsy test for treatment selection in advanced-stage cancer.
- Guardant360 CDx – an FDA-approved companion diagnostic test, referenced as being used for targeted therapies in advanced cancers and as the technology basis for in-house testing at partner hospitals.
- Guardant Omni – mentioned in Polygon data as a broader gene panel used for immuno-oncology research.
- Guardant Reveal – a tissue-free blood test for detecting minimal residual disease (MRD) and monitoring for recurrence in early-stage cancer. Company press releases also describe an expanded Guardant Reveal offering for late-stage therapy response monitoring, tracking more than 20,000 epigenomic (methylation) signals to measure changes in ctDNA levels.
- Guardant360 Liquid – a comprehensive multiomic profiling test that leverages the company’s proprietary epigenomic technology, used in studies of early and metastatic breast cancer to monitor treatment response and tumor evolution.
- Shield – a non-invasive, blood-based screening test for colorectal cancer (CRC). Guardant describes Shield as the first and only blood test approved by the U.S. Food and Drug Administration as a primary screening option for CRC, intended for average-risk individuals age 45 or older.
Guardant highlights that several of these offerings are powered by its Guardant Infinity Smart Platform, which underpins its epigenomic technology and multiomic liquid biopsy capabilities.
Screening and early detection
In its public statements, Guardant Health emphasizes the role of its tests in screening and early detection. Shield is positioned as a primary screening option for colorectal cancer that can be completed with a blood draw during a healthcare visit. The company notes that Shield detects alterations associated with colorectal cancer in blood and is intended for individuals at average risk, age 45 or older. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and should be followed by colonoscopy evaluation.
Guardant also reports that Shield is covered by Medicare and the Veterans Affairs Community Care Network and is commercially available across the United States. In a separate announcement, the company states that Shield is covered for active-duty service members and eligible family members through TRICARE, with no copay for average-risk individuals ages 45 and older, expanding access to colorectal cancer screening in the U.S. military population.
Monitoring, MRD, and therapy response
Beyond screening, Guardant Health’s tests are used for monitoring recurrence and assessing treatment response. Guardant Reveal is described as a tissue-free MRD test that detects ctDNA to identify minimal residual disease and monitor for recurrence in early-stage cancer. The company further notes that Guardant Reveal has been expanded to include late-stage therapy response monitoring for patients with solid tumors, predicting outcomes sooner than imaging and without the need for a tissue sample.
Guardant reports that Reveal tracks more than 20,000 epigenomic (methylation) signals in blood to measure ctDNA changes and that clinical evidence supports its use in monitoring chemotherapy and immunotherapy response across multiple solid tumor types. Company communications highlight studies in breast cancer, where Guardant Reveal has shown prognostic significance in neoadjuvant settings and in predicting relapse risk.
Guardant360 Liquid is described as a multiomic liquid biopsy test that can provide methylation-based breast cancer subtyping and monitor tumor evolution. According to company summaries of scientific presentations, Guardant360 Liquid has demonstrated agreement with tissue-based monitoring in breast cancer and has been used to reassess hormone receptor and HER2 status in metastatic disease.
Advanced cancer and treatment selection
Guardant Health states that its blood and tissue tests support treatment selection for patients with advanced cancer. Guardant360 LDT and Guardant360 CDx are used for molecular profiling of solid tumors, enabling clinicians to identify genomic alterations that may inform targeted therapies. The company notes that Guardant360 CDx has received certification under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746) for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications in advanced non-small cell lung cancer and breast cancer.
Guardant’s tests are also used by pharmaceutical companies and academic researchers in clinical trials. In public communications, the company describes its diagnostics as tools to accelerate precision medicine drug development and to support clinical research at major cancer centers.
Real-world data, AI analytics, and data infrastructure
Guardant Health repeatedly highlights its use of real-world data and AI analytics. The company states that its growing platform includes data from more than 1 million patients tested, which supports identification of patients for precision oncology clinical trials based on biomarker and clinical data. Guardant has announced collaborations that integrate its genomic data with AI-powered platforms to match patients to clinical trials and provide navigation support, with an emphasis on expanding access for representative and underserved populations.
In addition, Guardant has taken a role in data infrastructure initiatives. The company announced the launch of the Single Namespace Working Group, a cross-industry consortium that drafted an open standard for exabyte-scale data interoperability. Guardant describes this effort as focused on enabling AI-ready infrastructure and secure, interoperable access to large, distributed datasets, such as genomic data used in healthcare and life sciences.
Partnerships and global footprint
Guardant Health’s disclosures describe partnerships with healthcare institutions and technology companies. In Europe, the company announced the launch of FPG 360, an in-house liquid biopsy testing service at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome, Italy, based on Guardant360 CDx technology. The company notes that FPG 360 is one of the first dedicated liquid biopsy testing facilities in Italy housed within a hospital system and that it supports both routine care and clinical research. Guardant also references partnerships with Val d’Hebron/VHIO in Barcelona and The Royal Marsden Hospital in London.
In the United States, Guardant reports collaborations with Trial Library to increase access to oncology clinical trials by combining Guardant’s precision oncology diagnostics and real-world data with Trial Library’s AI-powered matching and navigation platform. The company also notes payer coverage milestones for Shield, including Medicare, the Veterans Affairs Community Care Network, and TRICARE for U.S. military members and families.
Capital markets and corporate profile
Guardant Health’s common stock trades on The Nasdaq Global Select Market under the ticker symbol GH, as stated in its SEC filings. The company has used public equity offerings and convertible senior notes to raise capital, as described in its Form 8-K filings. These filings outline an underwriting agreement for a public offering of common stock and a private offering of 0.00% Convertible Senior Notes due 2033, with the company indicating that net proceeds are expected to be used for general corporate purposes.
Guardant’s SEC filings and press releases also reference its participation in healthcare and investor conferences and its governance structure, including board appointments and stockholder meeting outcomes. The company emphasizes that its operations and disclosures are subject to U.S. securities regulations, and it files reports and current event disclosures with the U.S. Securities and Exchange Commission.
Role in precision oncology
Across its public communications, Guardant Health presents itself as a precision oncology company that uses blood and tissue tests, real-world data, and AI analytics to provide insights throughout the cancer care journey. Its portfolio spans colorectal cancer screening (Shield), minimal residual disease and recurrence monitoring (Guardant Reveal), therapy response monitoring in advanced disease, and comprehensive genomic profiling for treatment selection (Guardant360 LDT and Guardant360 CDx), as well as research-oriented panels (Guardant Omni). The company positions its technologies as tools for clinicians, researchers, and biopharmaceutical partners to detect cancer earlier, monitor disease more precisely, and tailor treatments based on molecular information.