GGuardant Health develops blood-based cancer diagnostics and sells tests to healthcare providers and research institutions. Its flagship product, Guardant360, uses a liquid biopsy to analyze tumor DNA circulating in a patient’s blood to detect mutations and guide treatment decisions for advanced cancer. The company is expanding into early detection and recurrence monitoring, with tests designed to be non-invasive and data-rich for cancer management. Compared with competitors, Guardant Health emphasizes a widely adopted, FDA-approved liquid biopsy platform with broad cancer-type coverage and a focus on providing actionable genomic insights to clinicians. Its goal is to improve cancer outcomes by enabling non-invasive, data-driven decision making across stages of disease and over time.
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2012
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Guardant Health reported that 99% of patients completed its Shield blood test for colorectal cancer in two rural South Carolina clinics. The company says the result shows a simple blood draw can close screening gaps in underserved communities. Shield adoption and reimbursement will drive how fast the company's losses narrow. Guardant still faces cash burn and negative equity, and the adherence data does not remove that financing risk. Analysts expect 33.7% yearly revenue growth, reaching $2.8 billion by 2029. They forecast earnings of $106.1 million by then, against a current loss of $453.4 million. A more cautious view assumes 28.3% growth to about $2.5 billion.
Guardant Health Shield blood test demonstrates leading screening adherence and CRC deaths averted compared to stool-based tests. October 15, 2026 * Modeling study provides strong data on real-world follow-up colonoscopy adherence and CRC deaths averted for blood-based testing vs stool-based testing * New data demonstrates notable screening adherence rate of 99% in medically-underserved populations for Shield blood-based colorectal cancer (CRC) screening test PALO ALTO, Calif.-(BUSINESS WIRE)- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators presented new data showing the critical role of blood-based testing in increasing overall colorectal cancer (CRC) screening and follow-up colonoscopy adherence at the American College of Gastroenterology (ACG) 2026 Annual Meeting in Nashville, Tennessee. A modeling study looking at individuals 45 to 75 over a lifetime projected the health outcomes of blood-based testing compared to other non-invasive tests using real-world evidence for follow-up colonoscopy adherence, showing that blood-based screening may increase rather than lower the need for colonoscopy by bringing more patients into the screening pathway. With longitudinal test adherence and real-world follow-up colonoscopy adherence (FU-CY), blood-based screening increased the number of colonoscopies (679 vs. 113 and 326) and also averted more CRC deaths (12 vs. 6 and 9) compared to FIT and mt-sDNA testing per 1,000 simulated individuals during their lifetime. Building off findings from Guardant Health's 2025 study in Appalachia, another key study looked at clinical implementation of Shield in two rural health clinics in South Carolina which demonstrated a 99% real-world adherence rate, well above average screening adherence for overall CRC testing which ranges from 28-71%[12]. The notable findings reiterate the impact of blood-based tests in increasing CRC screening participation and improving outcomes, particularly for medically-underserved communities. "Today's research continues to reinforce the data we've seen across Guardant's robust real-world evidence: blood-based screening meaningfully closes gaps in colorectal cancer screening participation with a significant lift in underserved communities that face some of the most persistent access barriers," said Sam Asgarian, Guardant Health's VP of Clinical Affairs. "For the first time, we've been able to correlate the impact of real-world follow-up colonoscopies and screening adherence with the modeling studies of the Shield blood test. We're proud to present this compelling research with our collaborators at ACG and to continue to demonstrate Shield's role as a clinically meaningful alternative to traditional screening methods." Shield was purpose-built to close screening gaps in population health, as the most-clinically validated blood test in market and the first blood test to receive FDA approval as a primary screening option for CRC in average-risk adults 45 and older. With more than 200,000 tests performed in real-world settings, Shield is proven to significantly increase overall CRC screening completion for patients due for CRC screening across practice and health system settings, demonstrating over 90% screening adherence.[3] The full abstracts for Guardant Health and a list of all abstracts presented at the ACG Annual Meeting can be found here. About Shield Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant 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. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Guardant Health Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health's liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health's views as of any date subsequent to the date of this press release. [1] Gellad ZF, Stechuchak KM, Fisher DA, et al. Longitudinal adherence to fecal occult blood testing impacts colorectal cancer screening quality. Am J Gastroenterol. 2011;106(6):1125-1134. [2] Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172(7):575-582. [3] Graham-Adderton C, Guerra CE, Ngo-Metzger Q, Hoang T, Raymond VM. Implementation of blood-based colorectal cancer screening: real-world adherence and outcomes. Curr Med Res Opin. 2025;41(10):1915-1920. doi:10.1080/03007995.2025.2582257
Guardant Health has received FDA approval for its Guardant360 CDx liquid biopsy as a companion diagnostic in advanced HR-positive, HER2-negative breast cancer. This marks the first FDA-approved liquid biopsy companion diagnostic for longitudinal ctDNA testing in breast cancer care. The approval is supported by clinical trial data where early detection of ESR1 mutations using Guardant360 CDx informed treatment changes for patients. The decision shifts Guardant Health's narrative towards recurring testing potential rather than one-off test sales. The approval reinforces adoption of Guardant's platform for ongoing treatment management beyond initial genomic profiling. Investors will monitor how ordering patterns for Guardant360 CDx appear in volume and revenue disclosures in upcoming quarterly reports.
The US Food and Drug Administration has approved Guardant360 CDx as a companion diagnostic to identify patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who may benefit from AstraZeneca's ETCAMAH (camizestrant). This marks the first FDA-approved liquid biopsy companion diagnostic for longitudinal testing in breast cancer. The approval is based on data from the SERENA-6 clinical trial, which used circulating tumour DNA monitoring to detect ESR1 resistance mutations before radiographic disease progression. Patients who switched to ETCAMAH following mutation detection experienced a 56% reduction in the risk of progression or death and 74% longer median progression-free survival compared to continuing standard treatment. Approximately 37,000 women in the US living with advanced HR-positive breast cancer could potentially benefit from this approach. This marks Guardant360 CDx's 29th companion diagnostic indication across multiple tumour types globally.
A US court has ordered Guardant Health to pay $245.2m to TwinStrand Biosciences and the University of Washington for infringing patented DNA sequencing technologies. The ruling upholds a November 2023 jury verdict finding Guardant liable for using Duplex Sequencing technology without authorisation. The infringement spans 11 Guardant products, including its Guardant360 CDx cancer detection assay. Of the total penalty, $119.4m represents royalties for sales between February 2024 and May 2026. Guardant must also pay ongoing 6% royalties on covered products through March 2033 when the patents expire. TwinStrand spun out from the University of Washington in 2015. Duplex Sequencing achieves 10,000-fold greater accuracy than conventional methods, according to the company. Guardant rejected the decision and plans to appeal. "We strongly disagree with this decision and will promptly be appealing for its overturn," said chief legal officer John Saia.
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Industries
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Palo Alto, California
Founded
2012
Find jobs on Simplify and start your career today