FDA APPROVED FOR COLORECTAL CANCER (CRC) SCREENING

Make screening easy with Shield™

Improve adherence with the ability to screen right in your office with Shield, an accurate, FDA-approved blood test for CRC screening1,2

Screen with Shield

Shield can help overcome screening challenges1

The only FDA-approved blood test available for CRC screening with Medicare coverage

Convenient

Can be completed in your office at any patient visit

Quick

You will receive test results in ~2 weeks

Simple

As easy as doing a complete blood count

Offer Shield as a CRC
screening option

Help patients choose a screening method that works for them with shared decision making

2.4x

increase in screening rates when Shield was offered1

Alongside colonoscopy and FIT. Based on a study of over 1000 patients, age 45-75, at a large, integrated health system. There was a statistically significant difference in screening completion rate between the "usual care" group (FIT and colonoscopy), and the "intervention" group (usual care + Shield). Data based on Laboratory Developed Test (LDT) usage of Shield, which has not been cleared or approved by the FDA

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With the Shield blood test,
you finally get accuracy and adherence2,3

The ECLIPSE study, published in the New England Journal of Medicine, included2:

  • More than 20,000 average-risk individuals, ages 45-84*†
  • A diverse population from over 200 clinical trial sites and 34 states that reflects US demographics
Access the publication

ECLIPSE demonstrated Shield's
ability to accurately detect CRC2

83%

overall CRC sensitivity

90%

specificity

See additional data
tube

Of the first 20,000 patients offered the Shield LDT,

9 out of 10 patients

completed screening with Shield3‡

*Patients had no prior diagnosis of CRC, inflammatory bowel disease, or hereditary predisposition to CRC (eg, Lynch syndrome)

†The clinical validation cohort included over 10,000 patients. 7861 patients were included in the final clinical validation cohort

‡Internal data on file, March 2024. Data from real-world clinical settings. Data based on LDT usage of Shield, which has not been cleared or approved by the FDA

Shield is a solution for low CRC screening adherence1,2

The barriers inherent to traditional modalities prevent people from getting screened, which can lead to late or missed diagnoses4,5

*Internal data on file, March 2024. Data based on LDT usage of Shield, which has not been cleared or approved by the FDA

Order Shield for your practice

“With the Shield test, I’m 100% confident that the patient has gotten the test done... because we draw blood in our office”

—
Daniel Ripley, MD
Family Practice
Physician

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 indicated 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 Stage II, III, and IV colorectal cancer.

Limitations and Other Important Information: The Shield test is not indicated 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. Coronado GD, Jenkins CL, Shuster E, et al. Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence. Gut. 2024;73(4):622-628. doi:10.1136/gutjnl-2023-330980
  3. Chung DC, Gray DM II, Singh H, et al. A cell-free DNA blood-based test for colorectal cancer screening. N Engl J Med. 2024;390(11):973-983. doi:10.1056/NEJMoa2304714
  4. Data on file. Guardant Health, Inc.
  5. Jones RM, Devers KJ, Kuzel AJ, Woolf SH. Patient-reported barriers to colorectal cancer screening: A mixed-methods analysis. Am J Prev Med. 2009:38(5):508-516. doi:10.1016/j.amepre.2010.01.021
  6. Meester RGS, Doubeni CA, Lansdorp-Vogelaar I, et al. Colorectal cancer deaths attributable to nonuse of screening in the United States. Ann Epidemiol. 2015;25(3):208-213.e1. doi: 10.1016/j.annepidem.2014.11.011
  7. National Cancer Institute. NCI Dictionary of Cancer Terms: negative predictive value. Accessed May 21, 2024. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/negative-predictive-value
  8. Shield™ Provider Brochure. Redwood City, CA: Guardant Health, 2024.