Guardant Health, Inc. develops precision oncology diagnostics and data products centered on blood and tissue testing for cancer care. Company news commonly covers the Guardant360 liquid biopsy and Guardant360 Tissue franchises, Guardant Reveal for molecular residual disease monitoring, Shield colorectal cancer screening, and InfinityAI real-world data and analytics.
Recurring updates include financial results across Oncology, Screening, and Biopharma & Data revenue categories; FDA companion diagnostic approvals for Guardant360 CDx; research presentations in tumor typing, therapy selection, methylation and multiomic testing; and biopharma collaborations that use Guardant tissue and liquid biopsy assays to support targeted therapy development.
Guardant Health (NASDAQ: GH) announced FDA approval of Guardant360 CDx as a companion diagnostic to identify BRAF V600E-mutant metastatic colorectal cancer (mCRC) patients eligible for BRAFTOVI (encorafenib) plus cetuximab and chemotherapy, supported by Pfizer’s Phase 3 BREAKWATER trial.
The approval expands Guardant360 CDx’s role across solid tumors as the platform’s 25th companion diagnostic indication, enables non-invasive ctDNA testing for rapid treatment selection and resistance monitoring, and complements existing Medicare and commercial coverage representing >300 million covered lives.
Guardant Health (Nasdaq: GH) announced a multi-year global collaboration with Merck (MSD outside US/Canada) to use the Guardant Infinity Smart platform across Merck’s oncology programs.
The agreement names Guardant’s liquid and tissue biopsy tests as clinical-trial enrolling assays, contemplates development of novel therapies using Guardant liquid biopsy tests as companion diagnostics, and includes partnering for global commercialization in the US, Asia-Pacific, UK, and EU.
Guardant Health (Nasdaq: GH) reported preliminary, unaudited results for Q4 and full-year 2025, with Q4 revenue of ~$280M (+39% YoY) and FY2025 revenue of ~$981M (+33% YoY). Test volumes rose sharply: ~79,000 oncology tests in Q4 (+38% YoY) and ~276,000 oncology tests for FY2025 (+34% YoY). Shield screening volumes reached ~38,000 in Q4 and ~87,000 for FY2025, with nearly 100,000 patients screened since FDA approval. Preliminary free cash flow was negative ~$54M in Q4 and negative ~$233M for FY2025. Cash and marketable securities totaled ~$1.3B at year-end. Results are unaudited and subject to change; audited results expected on the February 2026 earnings call.
Guardant Health (Nasdaq: GH) announced on January 8, 2026 that its Shield blood test for colorectal cancer screening is now covered by TRICARE for active-duty service members and eligible family members with no copay for average-risk individuals ages 45 and older. Shield is the first and only blood test approved by the FDA as a primary screening option for colorectal cancer and is already covered by Medicare and the Veterans Affairs Community Care Network. The Department of Defense reports about 1.3 million active-duty service members who, along with their screening-eligible family members, gain access to a blood-based alternative to traditional screening. Colorectal cancer has a 91% five-year survival rate when detected early.
Guardant Health (Nasdaq: GH) will participate in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco.
Management is scheduled to present and take part in a Q&A on Monday, January 12, 2026 at 3:45 p.m. PT / 6:45 p.m. ET. Live and archived webcasts will be available in the company Investors section at www.guardanthealth.com.
Guardant Health (Nasdaq: GH) announced a strategic collaboration with Trial Library on December 11, 2025 to expand access to oncology clinical trials across the U.S. The partnership pairs Guardant’s real-world genomic dataset of more than 1 million patients tested with Trial Library’s AI matching and navigation platform active in 320+ clinics and with 1,500 providers. The collaboration aims to streamline identification, referral, remote eligibility verification and longitudinal navigation to boost enrollment among representative and underserved populations.
Key figures cited include >70% of patients open to trials versus 7% enrolled
Guardant Health (Nasdaq: GH) announced on December 9, 2025 the launch of FPG 360, an in-house liquid biopsy testing service at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome, Italy. The facility will offer on-site testing based on Guardant360 CDx technology to support routine care and clinical research.
The collaboration is described as one of the first dedicated hospital-based liquid biopsy facilities in Italy and follows Guardant Health partnerships with Val d’Hebron/VHIO and The Royal Marsden. The release notes Italy records approximately 400,000 new malignant tumor cases annually and also references Guardant360 CDx certification under EU IVDR obtained last year.
Guardant Health (Nasdaq: GH) will present 14 abstracts at the 2025 San Antonio Breast Cancer Symposium (Dec 9–12, 2025) highlighting multiomic, tissue-free liquid biopsy data.
Key topics include Guardant Reveal for minimal residual disease (MRD) and Guardant360 Liquid multiomic profiling using methylation-based assays. Presentations report prognostic ctDNA signals: ctDNA correlated with pathological complete response and three-year invasive disease-free survival in HER2-positive neoadjuvant patients; earlier ctDNA relapse detection in triple-negative breast cancer; and methylation-based subtype monitoring that aligned with tissue subtyping and predicted real-world outcomes after endocrine therapy.
Guardant Health (Nasdaq: GH) announced the public launch of the Single Namespace Working Group (SNS), a 34-member consortium that drafted the first open standard for exabyte-scale data interoperability. The group, formed over the past 18 months, includes technology and life-science organizations such as NetApp, Seagate, IBM, DDN, Genentech and major national laboratories.
The consortium is transitioning its work to the international standards body OASIS for publication of open specifications. Draft specifications are expected in early 2026, and public discussions are planned during Supercomputing 2025 in St Louis, MO.
Guardant Health (Nasdaq: GH) expanded its tissue-free Guardant Reveal blood test on November 10, 2025 to include late-stage therapy response monitoring for patients with solid tumors.
Reveal analyzes >20,000 epigenomic methylation signals in circulating tumor DNA to predict therapy response across immunotherapy and chemotherapy, can be initiated anytime during treatment, and returns actionable insights in seven days. Clinical validation cited includes a pan-cancer chemotherapy study showing prediction of long-term benefit up to 18 months earlier and the RADIOHEAD study showing immunotherapy responses detected up to 5 months earlier than standard imaging. A new universal one-click ordering option was also launched to streamline physician ordering across Guardant’s portfolio.