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Guardant Health Stock Price, News & Analysis

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Welcome to our dedicated page for Guardant Health news (Ticker: GH), a resource for investors and traders seeking the latest updates and insights on Guardant Health stock.

Guardant Health (GH) is a leader in precision oncology, pioneering non-invasive liquid biopsy tests for cancer detection and monitoring. This dedicated news hub provides investors and healthcare professionals with timely updates on the company's financial performance, clinical advancements, and strategic initiatives.

Access authoritative coverage of earnings reports, regulatory milestones, and technology innovations shaping cancer diagnostics. Our curated collection includes press releases on clinical trial results, partnership announcements, and peer-reviewed research developments directly from Guardant Health's communications.

Key updates cover FDA clearances for diagnostic assays, global commercialization efforts, and data partnerships advancing precision medicine. Stay informed about developments in molecular residual disease detection, expanded test indications, and reimbursement progress affecting healthcare adoption.

Bookmark this page for consolidated access to verified information about liquid biopsy advancements and GH's role in transforming cancer care through genomic insights. Check regularly for objective reporting on developments impacting both clinical practice and investment considerations.

News

FDA Grants Breakthrough Device Designation to Guardant Health’s Shield Multi-Cancer Detection (MCD) Test

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Guardant Health (GH) has received FDA Breakthrough Device designation for its Shield multi-cancer detection (MCD) test, a blood-based screening tool for eight different cancer types in individuals aged 45 or older. The test uses methylation-based technology to detect bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreas cancers. Clinical validation data presented at ASCO 2025 demonstrated impressive performance metrics: 98.6% specificity, 75% overall cancer sensitivity (ranging 62-96% per cancer type), and 92% accuracy in identifying cancer signal origin. The test was also selected by the National Cancer Institute for its Vanguard Study evaluating emerging MCD technology. This FDA designation aims to accelerate development and review processes for devices showing potential in life-threatening disease treatment or diagnosis.
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National Comprehensive Cancer Network (NCCN) Updates Colorectal Cancer Screening Guidelines to Include Shield Blood-Based Screening

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Guardant Health (GH) announced a significant milestone as its Shield blood test has been included in the National Comprehensive Cancer Network's (NCCN) updated colorectal cancer screening guidelines. The Shield test, which detects circulating tumor DNA in blood, is FDA-approved for adults aged 45+ at average cancer risk and is recommended for testing every three years. The inclusion is supported by the landmark ECLIPSE study, published in the New England Journal of Medicine, which demonstrated Shield's 83% sensitivity in detecting colorectal cancer compared to screening colonoscopy. This development represents a major advancement in making colorectal cancer screening more accessible through a simple blood draw alternative.
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SERENA-6 Phase III Trial Demonstrates Clinical Value of Guardant360 CDx Test to Detect Emergence of Endocrine Resistance and Inform a Switch in Therapy Before Radiological Disease Progression in Advanced Breast Cancer

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Guardant Health (GH) announced breakthrough results from the Phase III SERENA-6 trial, showcasing the effectiveness of their Guardant360 CDx liquid biopsy test in detecting early endocrine resistance in breast cancer treatment. The trial demonstrated that using Guardant360 CDx to detect ESR1 mutations and switching patients to AstraZeneca's camizestrant resulted in a 56% reduction in disease progression or death risk in HR-positive breast cancer patients. This groundbreaking study, published in The New England Journal of Medicine, is the first global Phase III trial using ctDNA monitoring to guide therapy changes before radiological disease progression, potentially establishing a new paradigm in breast cancer treatment.
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In Largest Molecular Residual Disease (MRD) Study in Colon Cancer, Guardant Reveal Testing Prior to Chemotherapy Provides Robust Stratification for Risk of Disease Recurrence and Survival to Enable Timely Treatment Decisions

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Guardant Health (GH) presented groundbreaking results from the largest molecular residual disease study in colon cancer at ASCO 2025. The study, involving over 2,000 stage III colon cancer patients with 6.1 years median follow-up, demonstrated the effectiveness of their Guardant Reveal blood test in predicting cancer recurrence risk and survival outcomes. The test detected that 62.6% of patients with post-surgical circulating tumor DNA (ctDNA) experienced cancer recurrence within 3 years despite chemotherapy, compared to only 15.4% in patients with undetectable ctDNA. This breakthrough enables better identification of high-risk patients who may need more aggressive treatment, as approximately 30% of stage III colon cancer patients typically relapse after surgery despite standard chemotherapy.
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Guardant Health Introduces Nearly a Dozen Groundbreaking Smart Liquid Biopsy Applications for Guardant360 Liquid Test

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Guardant Health (NASDAQ: GH) has unveiled significant enhancements to its Guardant360® Liquid test, introducing nearly a dozen new smart liquid biopsy applications. The expanded capabilities, powered by the Guardant Infinity™ platform and AI learning engine, enable comprehensive tumor analysis through a simple blood test. Key innovations include: confirming absence of actionable mutations in lung and colorectal cancers, identifying cancer origin for unknown primary sites, classifying breast and lung cancer subtypes through methylation signatures, utilizing pharmacogenomics for therapy safety, detecting HPV and EBV viruses, determining HRD status, and performing HLA genotyping. The test delivers results within seven days and provides molecular profiling information traditionally obtained through tissue-based immunohistochemistry, representing a significant advancement in non-invasive cancer diagnostics.
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Guardant Health and Collaborators to Present Over 19 Studies Demonstrating Role of Liquid Biopsy in Advancing Precision Oncology at 2025 ASCO Annual Meeting

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Guardant Health (GH) will present data from over 19 studies at the 2025 ASCO Annual Meeting, showcasing their liquid biopsy tests' role in cancer care. Key highlights include: 1) A plenary session featuring the Phase 3 SERENA-6 trial demonstrating Guardant360 CDx test's ability to detect ESR1 mutations in breast cancer patients, 2) An oral session presenting the largest study of Guardant Reveal for molecular residual disease detection in colon cancer, involving over 2,000 patients with 6.1 years median follow-up, 3) Validation of an algorithm predicting absence of actionable mutations in colorectal and lung cancers, and 4) Application of epigenomic-based classifier for identifying tumor types in cancer of unknown primary origin. The presentations span various applications including cancer screening, therapy selection, and recurrence monitoring across multiple solid tumor types.
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Guardant Health Introduces Comprehensive Immunohistochemistry Testing for Solid Tumors

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Guardant Health (Nasdaq: GH) has expanded its testing portfolio by introducing a comprehensive immunohistochemistry (IHC) testing suite for solid tumors. The new tests detect specific proteins (biomarkers) in tissue samples to help oncologists identify tumor characteristics and match patients with targeted therapies. The IHC suite covers key biomarkers including HER2, MMR, PD-L1, c-MET, ER, PR, Ki-67, CLDN18, and FOLR1.

This addition complements Guardant's existing Guardant360 Tissue multiomic tumor profiling test. Notably, the suite includes testing for c-MET, which is crucial for identifying patients eligible for the newly FDA-approved Emrelis™ treatment for c-MET-expressing non-squamous non-small cell lung cancer (NSCLC).

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Guardant Health Introduces Hereditary Cancer Testing to Identify Inherited Predispositions to Certain Types of Cancer

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Guardant Health (NASDAQ: GH) has launched the Guardant Hereditary Cancer test, a blood-based germline panel test that identifies genetic variants linked to cancer risk. The test analyzes 82 genes associated with increased risk for more than 12 tumor types, including breast, colorectal, prostate, endometrial, and renal cancers. This germline testing helps guide treatment decisions and enables healthcare providers to assess patient risk for secondary cancers. The test requires a simple blood draw, can be ordered standalone or added to Guardant360 liquid biopsy tests, and delivers results in 2-3 weeks. The launch expands Guardant's precision oncology portfolio and supports healthcare providers across the cancer care continuum.

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Guardant Health to Participate in Upcoming Investor Conferences

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Guardant Health (Nasdaq: GH), a precision oncology company, has announced its participation in three major upcoming investor conferences in 2025:

  • BofA Securities Healthcare Conference in Las Vegas - May 14th at 3:40 PM PT
  • Jefferies Global Healthcare Conference in New York - June 4th at 2:35 PM ET
  • Goldman Sachs Global Healthcare Conference in Miami Beach - June 9th at 10:00 AM ET

The company will participate in fireside chat sessions at each event. Live and archived webcasts will be available on Guardant Health's investor relations website.

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TIME Names Guardant Health Co-CEOs to 2025 TIME100 Health List of the 100 Most Influential People in Global Health This Year

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TIME has named Guardant Health (NASDAQ: GH) co-CEOs Helmy Eltoukhy and AmirAli Talasaz to its prestigious 2025 TIME100 Health list, recognizing the most influential people in global health. The recognition highlights Guardant's achievements in precision oncology, particularly their Shield blood test for colorectal cancer, which is FDA-approved for primary non-invasive screening in average-risk individuals aged 45 and older. The company recently presented promising data for their multi-cancer detection blood test at the AACR annual meeting. Guardant's technology aims to replace invasive biopsies, enable faster treatment decisions, and advance early cancer detection capabilities.
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FAQ

What is the current stock price of Guardant Health (GH)?

The current stock price of Guardant Health (GH) is $48.06 as of June 6, 2025.

What is the market cap of Guardant Health (GH)?

The market cap of Guardant Health (GH) is approximately 4.8B.
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Guardant Health

Nasdaq:GH

GH Rankings

#1290 Ranked by Market Cap
N/A Ranked by Dividends

GH Stock Data

4.78B
118.04M
4.71%
98.48%
6.4%
Diagnostics & Research
Services-medical Laboratories
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United States
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