FDA-Approved Blood Test Revolutionizes Colorectal Cancer Screening

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced its Shield blood test for colorectal cancer (CRC) screening has been named a winner of Fast Company’s 2025 World Changing Ideas Awards. These annual awards recognize innovative companies and projects addressing the world’s most urgent challenges.

Shield is the first blood test approved by the U.S. Food and Drug Administration (FDA) as a primary screening option for CRC. The second leading cause of cancer-related deaths in the U.S., CRC has a 91 percent five-year survival rate if caught in early stages. Yet one out of three eligible adults in the U.S. (over 50 million people) do not complete the recommended screening in part because they find the available options—colonoscopy and stool tests—unpleasant or inconvenient. With Shield, individuals can be screened with a simple blood draw during a routine office visit, helping to detect more cancers early, when they are more treatable.

“With a simple blood draw, Shield provides a more convenient and pleasant screening option for the millions of people who delay their recommended screening for colorectal cancer,” said AmirAli Talasaz, Guardant Health co-founder and co-CEO. “This latest honor for Shield recognizes the groundbreaking innovation created by our team at Guardant Health and the world-changing potential of the Shield blood test. By overcoming barriers with current screening methods, we can help increase the overall screening rate, find more cancers at an early stage, and give people more time free from cancer.”

A panel of Fast Company editors and reporters selected the winners from a pool of more than 1,500 entries and judged applications based on their impact, sustainability, design, creativity, scalability, and ability to improve society. This year’s awards are featured on fastcompany.com.

“The World Changing Ideas Awards have always been about showcasing the art of the possible,” says Fast Company editor-in-chief Brendan Vaughan. “We’re proud to recognize the organizations and leaders that are making meaningful progress on the biggest issues of our time.”

The Shield blood test was also named to TIME’s list of the best inventions of 2024 and selected as a Grand Award Winner in Popular Science’s Best of What’s New 2024 (Health category). Shield is also the first blood test that is FDA approved for primary screening to be included in The National Comprehensive Cancer Network (NCCN) colorectal cancer (CRC) screening guidelines.

Shield is FDA approved for primary non-invasive screening for colorectal cancer in average-risk individuals age 45 and older and can be ordered by any prescribing healthcare provider. For more information, visit www.ShieldCancerScreen.com.

About Shield

Shield is a 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, 2024, and any current and periodic reports filed with or furnished to the Securities and Exchange Commission thereafter. 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.