FDA APPROVED FOR COLON CANCER SCREENING

Why screen for colon cancer with Shield™?

Shield is a more pleasant screening option

Shield is an FDA-approved test that can be done at any healthcare provider visit with a simple blood draw

Simple blood draw

Sample collected in minutes

No handling of stool

Results in ~2 weeks

How Shield works:

The Shield test detects signals for colon cancer from DNA shed into the blood1,2

The performance of Shield has been established in the ECLIPSE clinical study of average-risk adults aged 45-84 using colonoscopy as the reference method, with over 10,000 patients: sensitivity is 83% for the detection of CRC and specificity is 90%

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As cancerous tumors grow...

cancerous DNA is released into the bloodstream.

Shield looks for this cancerous DNA to identify signals that are associated with colorectal cancer.

Patients with a "positive" result should be followed by colonoscopy. A ”negative" result indicates a signal associated with colorectal cancer was not detected.

Understanding your results

You and your healthcare provider will receive your test results in approximately two weeks

This is what your results mean*:

Negative: Signals associated with colon cancer tumors were not found2

Positive: Raises concern for the presence of a tumor in the colon or rectum. A colonoscopy is necessary to determine the presence of colorectal cancer2

Shield has limited ability to detect advanced adenomas, also known as advanced precancerous polyps

*Shield may produce a false negative or false positive result

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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. 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/NAEJMoa2304714
  3. Shield™ Provider Brochure. Redwood City, CA: Guardant Health, 2024