Guardant Health Stock Price, News & Analysis

Guardant Health (Nasdaq: GH) reported Q3 2025 revenue of $265.2M, up 39% YoY, driven by Oncology, Screening, and Biopharma & Data. The company raised full‑year 2025 revenue guidance to $965–$970M (≈31% growth) and now expects Screening revenue of $71–$73M from ~80,000–82,000 Shield tests. Q3 non‑GAAP gross margin was 66%. Q3 net loss narrowed to $92.7M and non‑GAAP net loss was $48.3M. Cash and equivalents were $689.5M. Management cited expanded Shield MCD, new partnerships, Guardant360 PMA submission, and FDA companion diagnostic approvals as key operational milestones.

Guardant Health (Nasdaq: GH) and Zephyr AI announced a strategic partnership on October 27, 2025 to combine multimodal molecular and clinical real-world data with AI/ML to identify novel cancer biomarkers, predict targeted therapy response, and support biopharma drug development.

The collaboration will integrate Zephyr AI’s analytics with Guardant’s Infinity AI capabilities to generate biologically interpretable, real-world‑validated predictions for therapy selection and response monitoring, aimed at accelerating precision oncology research and enabling actionable insights for oncologists and developers.

Guardant Health (Nasdaq: GH) will present data at ACG 2025 showing blood-based testing can boost cancer screening adherence. An expanded cohort of 20,000 patients confirmed Shield delivered an adherence rate of over 90% for colorectal cancer screening, versus typical overall CRC screening adherence of 28–71%. Shield is the first and only FDA-approved blood test as a primary screening option for average-risk adults aged 45 and older. A separate Cedars Sinai-led survey of >1,700 US adults found 43.9% of screening-eligible individuals prefer a blood test for colorectal and lung cancer versus traditional methods. Guardant and collaborators will present multiple abstracts and posters at ACG 2025 in Phoenix, Oct 24–29, 2025.

Guardant Health (Nasdaq: GH) will present 15 abstracts at the ESMO Congress 2025 in Berlin, Oct 17–21, covering work across the cancer care continuum.

Presentations showcase blood-based assays for MRD detection, recurrence monitoring, tumor profiling, and therapy response across multiple tumor types including lung, colorectal, breast, head and neck, and cancers of unknown primary. Key technologies highlighted include Guardant Reveal, Guardant360, and Guardant Infinity with data from studies such as CROWN, PEGASUS, PRECISION, SIBYL, CUPIDO, and others.

Selected topics: molecular lung subtyping, FGFR alteration landscapes in NSCLC, ctDNA-guided adjuvant decisions in colorectal cancer, and ctDNA monitoring after chemoradiation in head and neck cancers.

Guardant Health (Nasdaq: GH) will report third quarter 2025 financial results after market close on Wednesday, October 29, 2025. Company management will host a webcasted conference call starting at 1:30 p.m. PT / 4:30 p.m. ET. Live audio will be available on the company’s Investors website at www.guardanthealth.com. The webcast will be archived and available for replay after the event.

Guardant Health (NASDAQ:GH) has received FDA approval for its Guardant360 CDx as a companion diagnostic for Eli Lilly's Inluriyo (imlunestrant) in treating advanced breast cancer patients with ESR1 mutations. The diagnostic test helps identify patients with estrogen receptor-positive (ER+), HER2-negative advanced or metastatic breast cancer who may benefit from Inluriyo treatment after endocrine therapy progression.

The approval is significant as ESR1 mutations affect 40% of HR+, HER2- advanced breast cancers. In the Phase 3 EMBER-3 trial, Inluriyo demonstrated a 38% reduction in risk of progression or death compared to endocrine therapy. This marks Guardant360 CDx's sixth FDA-approved companion diagnostic claim and its second indication in breast cancer treatment.

Guardant Health (NASDAQ: GH) and Quest Diagnostics (NYSE: DGX) have announced a strategic collaboration to expand access to Guardant's Shield™ blood-based colorectal cancer screening test across the United States. The Shield test, which is FDA-approved for average-risk adults aged 45 and older, will be available through Quest's extensive network of approximately 650,000 clinician and hospital accounts.

The partnership will enable physicians to order Shield directly through their existing Quest accounts and EHR systems. Patients will have access to blood draws at Quest's 2,000 service centers and 6,000 in-office phlebotomists. The test is expected to launch through Quest in Q1 2026. Shield is currently covered by Medicare and the Veterans Affairs Community Care Network.

Guardant Health (Nasdaq: GH), a leading precision oncology company, has appointed Alex M. Azar II to its board of directors. Azar, the former 24th Secretary of the U.S. Department of Health and Human Services (HHS), brings significant healthcare leadership experience from both public and private sectors.

During his tenure at HHS, Azar oversaw critical agencies including the Centers for Medicare and Medicaid Services, FDA, and CDC. His extensive experience includes serving as President of Lilly USA, LLC, and holding various executive positions. Currently, he serves on multiple boards and advisory positions, including roles at the Aspen Institute, LifeScience Logistics, and Stanford University School of Medicine.

Guardant Health (Nasdaq: GH) has announced a strategic partnership with LabFlorida/SunDx Labs to expand access to Guardant Shield™, the first FDA-approved blood test for colorectal cancer (CRC) screening, to senior living communities. Through this agreement, LabFlorida will be the exclusive distributor for Shield across senior living facilities in Florida.

The partnership aims to address a critical healthcare gap, as up to 71% of assisted living residents are not current with CRC screening. Shield offers a simple blood draw alternative to traditional screening methods, targeting the 1-2 million individuals in senior living communities who are at increased risk of colorectal cancer due to age. The test could significantly improve screening rates for this vulnerable population, where CRC is the second leading cause of cancer-related deaths with a 91% five-year survival rate if detected early.