FDA APPROVED FOR COLON
CANCER SCREENING

Why screen for
colon cancer?

Colon cancer screening saves lives so you can be there for the people you love

We understand there are barriers to staying up to date with colon cancer screening. With Shield™, screening can be a more pleasant experience

Did you know?

Colorectal cancer is the second-leading cause of cancer death in the U.S.1, yet it is one of the most treatable when caught early. The 5-year relative survival rate is 91% when detected early (stage I or II), compared to just 14% when found late (stage IV)3,4.

Survival rates are higher when colon cancer is detected in early stages1

Early stage (I-II)

0%
vs

Late stage (IV)

0%

5-year relative survival rates based on stage at diagnosis

Colon cancer screening saves lives

~75%

of people who died from colon cancer were not up to date with screening2

Ask your healthcare provider about screening with the Shield test today

What is colorectal cancer?

Colorectal cancer (CRC) begins in the colon or rectum. Leading health organizations, including the US Preventive Services Task Force and the American Cancer Society, recommend screening for adults 45 and older with average risk and no symptoms. The goal of screening is simple: detect cancer early and reduce mortality5.

Why is screening important?

Several CRC screening modalities are available. No colorectal cancer screening test is perfect. Each test has different sensitivity. Since CRC often develops without symptoms in its early stages, regular screening offers the best chance of finding it when treatment is most effective.

Ask your healthcare provider about screening with the Shield test today
Why Shield

Important Product Information

Intended Use

The Shield™ test is a qualitative, in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Shield Blood Collection Kit.
Shield is intended for colorectal cancer screening in individuals at average risk for the disease, age 45 years or older. Patients with a positive result should be followed by colonoscopy. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. This test is performed at Guardant Health, Inc.

Precaution: Based on data from clinical studies, Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous lesions. One out of 10 patients with a negative Shield result may have a precancer that would have been detected by a screening colonoscopy. Shield demonstrated high detection of Stages II, III, and IV colorectal cancer.

Limitations and Other Important Information: The Shield test is not intended for patients that have personal history of colorectal cancer, adenomas, or other related cancers; or those who had a positive result on another colorectal cancer screening method within the last six months, have been diagnosed with a condition associated with high risk for colorectal cancer such as Inflammatory Bowel Disease (IBD), chronic ulcerative colitis (CUC), Crohn’s disease; or who have a family history of colorectal cancer, or certain hereditary syndromes. Providers should discuss the most appropriate screening test to use with patients depending on their medical history and individual circumstances. Shield may produce a false negative or false positive result. A false negative result may occur when the Shield test does not detect a colorectal tumor signal while a colonoscopy identifies a colorectal cancer. A negative result does not guarantee the absence of colorectal cancer or advanced adenoma, and patients should continue participating in colorectal cancer screening programs at the appropriate guideline-recommended intervals. A false positive result may occur when the Shield test generates a positive result while a colonoscopy will not find colorectal cancer or advanced adenoma.

Please read our Provider Brochure for complete product information about the Shield test including full safety information.

  1. References:
  2. National Cancer Institute. Cancer Stat Facts: Colorectal Cancer. Accessed May 7, 2024. https://seer.cancer.gov/statfacts/html/colorect.html
  3. Doubeni CA, Fedewa SA, Levin TR, et al. Modifiable failures in the colorectal cancer screening process and their association with risk of death. Gastroenterology. 2019;156(1):63-74. doi:10.1053/j.gastro.2018.09.040
  4. Siegel RL, Wagle NS, et al. Colorectal Cancer Statistics, 2023. CA Cancer J Clin. 2023;73(3):233-254.
  5. Siegel RL, Gianquinto AN, et al. Cancer Statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49.
  6. Shield Colorectal Cancer Screening Blood Test Fact Sheet for Patients. Accessed September 5, 2025.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009