American Cancer Society Recommends Guardant Health’s Shield Blood Test in Updated Colorectal Cancer Screening Guidelines

Key Terms

colorectal cancer (CRC) medical

Colorectal cancer (CRC) is a disease where abnormal cells grow in the colon or rectum, which are the final sections of the digestive tract; it can start as small growths and sometimes spread to other organs. Investors care because screening, treatment, and care for CRC drive demand for diagnostics, drugs, devices and services, and trial results, regulatory decisions, or changes in screening guidelines can materially affect the revenues and outlooks of healthcare companies, similar to how a new rule can change traffic for an entire industry.

blood-based CRC screening medical

A blood-based CRC screening test looks for signs of colorectal cancer in a small sample of blood rather than using invasive procedures like colonoscopy. For investors, these tests matter because they can expand the number of people who get screened, speed diagnosis, and create a scalable product with recurring sales and reimbursement implications—similar to a smoke detector that flags a problem early so more costly treatment can be avoided.

precision oncology medical

Precision oncology uses detailed biological information from a patient’s tumor—like genetic changes or specific markers—to choose treatments most likely to work for that individual, much like tailoring a suit to a person’s measurements instead of selling one-size-fits-all clothing. It matters to investors because these targeted approaches can improve treatment success, support premium pricing and companion diagnostic tests, and shorten development and approval timelines, creating focused markets with both higher potential returns and specialized risks.

screening adherence rate medical

The screening adherence rate measures the share of people who follow a recommended screening schedule — for example, showing up for a test, exam, or monitoring appointment when advised. Think of it like the percentage of drivers who bring their cars in for regular maintenance on time; higher rates mean the screening program or product is being used as intended. Investors care because adherence affects how well a health intervention performs, influences regulatory and reimbursement decisions, and drives real-world demand and revenue projections.

average-risk adults medical

Adults who do not have known medical conditions, family history, symptoms, or exposures that raise their chance of a specific disease above what is typical for the general population. For investors, this designation matters because products, tests, or screening programs aimed at average-risk adults target the largest, mainstream customer group and influence trial design, regulatory standards, market size, uptake, and revenue potential—like choosing whether to sell a product to all consumers or only a niche group.

New England Journal of Medicine (NEJM) medical

A leading, peer-reviewed medical journal that publishes clinical studies, reviews, and expert commentary on health and medicine. Investors watch its publications because study results or expert perspectives often act like a referee’s call—shaping regulators’ decisions, doctor adoption, and public confidence—and can quickly influence the value of drugmakers, device makers, and healthcare-related investments.

National Comprehensive Cancer Network (NCCN) regulatory

A non-profit alliance of cancer centers that develops widely used clinical practice guidelines — think of it as a rulebook or recipe for diagnosing and treating different cancers. These guidelines influence which treatments doctors choose, whether insurers will cover them, and how new therapies are adopted, so they can meaningfully affect a drug or device’s market access, sales potential, and the design of clinical trials.

guideline update regulatory

A guideline update is a formal change to an established set of recommendations or rules used by regulators, professional bodies, or industry groups—think of it as an updated recipe or rulebook for how a product, treatment, or process should be handled. Investors care because such updates can alter market demand, regulatory hurdles, development costs, or reimbursement prospects, which in turn can affect a company’s revenue prospects, required investments, and perceived risk.

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• Updated ACS guideline offers Shield as a new choice for over 50 million eligible Americans who are not up to date with their colorectal cancer screening
• Shield is the first and only FDA-approved blood test included in both ACS and NCCN guidelines

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced that its FDA-approved Shield™ blood test is now included in updated American Cancer Society (ACS) Colorectal Cancer (CRC) Screening Guidelines published today. The major screening guideline update recommends Shield as a choice for patients who decline or have not completed stool-based or visual examination screening tests.

In an effort to address persistent screening gaps and rising CRC rates in adults under 65, ACS guidelines now recommend Shield blood-based CRC screening as a new option to expand access and screening participation. Shield is the first and only FDA-approved blood test for primary colorectal cancer screening in average-risk adults age 45 and older and can be completed with just a blood draw during a routine doctor’s visit.

CRC is the second leading cancer killer in the United States¹ and the number one cancer killer for adults under 50.² The inclusion of Shield in the updated guidelines acknowledges a central challenge in colorectal cancer screening: more than 50 million eligible adults³ remain unscreened despite established methods like colonoscopy or stool-based testing existing for decades. By recognizing the effectiveness of a blood-based option, the updated guidelines add a new opportunity to reach patients who might otherwise go unscreened.

With three out of four CRC deaths among those not up to date with screening⁴, the American Cancer Society noted that “offering multiple, recommended screening options supports informed patient choice and may improve participation, because the most effective screening test is the one that the patient completes.”

“The inclusion of Shield in the American Cancer Society’s guidelines as a recommended option is a momentous step forward in our collective work to reach the more than 50 million Americans who remain unscreened for colorectal cancer,” said AmirAli Talasaz, Guardant Health co-CEO. “We know that tragically cancer does not wait. The Shield blood test has been proven to be effective in detecting cancers and increasing screening participation in the real-world setting. By making colorectal cancer screening more accessible with a blood-based option in conjunction with other established methodologies, we can get people screened.”

Guardant’s Shield blood test stood out in guideline evidence for having the highest screening adherence rate compared to traditional colonoscopies and stool-based tests.⁵ In the real-world experience with approximately 200,000 patients tested, Shield is proven to increase screening rates with over 90% of patients completing the test.⁶ In the pivotal ECLIPSE study, Shield showed its high sensitivity in detecting colorectal cancers and demonstrated sensitivity of 100% in detecting stage II and above cancers.⁷

“Screening rates have been largely stagnant across the population, with particular challenges in delivering screening to younger individuals age 45 to 55, racial and ethnic minoritized groups, and individuals with lower socioeconomic position. By providing the choice of a new CRC screening modality, blood-based testing has the potential to expand the reach of CRC screening to individuals who might otherwise remain unscreened,” said Samir Gupta, MD, Professor of Medicine at the University of California San Diego. “Today’s guideline update reflects the continued evolution of CRC screening-related technological advances, outlines persistent gaps in screening participation, and the potential for advances like blood-based testing to increase screening uptake.”

Demonstrating strong real-world evidence and clinical performance published in the New England Journal of Medicine (NEJM)⁷, Shield is the only FDA-approved blood test included in both ACS and National Comprehensive Cancer Network (NCCN) guidelines.

“The new ACS guidelines recognize that colorectal cancer screening is not one size fits all. Patients have several screening options, and their choices are impacted by where they live, their access to care, financial pressures, personal preferences, and individual risk factors,” said Anjee Davis, MPPA, CEO at Fight Colorectal Cancer. “As options expand, Fight CRC remains committed to patients making an informed choice, providing clear education, and ensuring timely follow up so more people can complete lifesaving screening. Our shared goal is clear: achieving 80% screening rates in every community.”

“Presenting patients with options helps them make educated health decisions,” said Chris Evans, President of the Colon Cancer Coalition. “The introduction of a blood-based choice for colorectal cancer screening will increase screening rates and ultimately save lives.”

ACS guidelines for colorectal cancer screening were last updated in 2018 to lower the recommended age for screening for adults at average risk from 50 to 45 in response to the rising rate of CRC among younger adults.

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 American Cancer Society. Key Statistics for Colorectal Cancer. Accessed online February 9, 2026. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html

² Scientific American. Colon cancer is killing more young people in the U.S. than any other cancer. January 22, 2026. https://www.scientificamerican.com/article/colon-cancer-is-killing-more-young-people-in-the-u-s-than-any-other-cancer/

³ American Cancer Society National Colorectal Cancer Roundtable. Colorectal Cancer Is A Major Public Health Problem. https://nccrt.org/our-impact/data-and-progress/.

⁴ Doubeni, C, et al. Modifiable Failures in the Colorectal Cancer Screening Process and Their Association with Risk of Death. Gastroenterology. 2019 Jan; 156(1): 63–74.e6.

⁵ Cullison J. A blood-based test for colorectal cancer screening. HCA Healthc J Med. 2025;6(6):571-573. doi:10.36518/2689-0216.2259.

⁶ Graham-Adderton, C., Guerra, C. E., Ngo-Metzger, Q., Hoang, T., & Raymond, V. M. (2025). Implementation of blood-based colorectal cancer screening: Real-world adherence and outcomes.

⁷ Chung, D. C., Gray, D. M., II, Singh, H., Issaka, R. B., Raymond, V. M., Eagle, C., Hu, S., et al. (2024). A cell-free DNA blood-based test for colorectal cancer screening. New England Journal of Medicine, 390(11), 973–983. https://doi.org/10.1056/NEJMoa2304714

View source version on businesswire.com: https://www.businesswire.com/news/home/20260526499046/en/

Investor Contact:
Zarak Khurshid
investors@guardanthealth.com

Media Contact:
Meaghan Smith
press@guardanthealth.com

Source: Guardant Health, Inc.