NOW FDA APPROVED FOR COLON CANCER SCREENING

Completing the Shield test

Frequently asked questions

  • Ask your healthcare provider if you can screen for colon cancer with Shield. Shield is by prescription only
  • You can ask your healthcare provider if you are eligible to screen with Shield. Your healthcare provider can then order Shield and you can get a blood draw either at their office or at a nearby lab. You will receive your results in approximately two weeks
  • Shield requires no fasting. Like all blood tests, it is important to stay hydrated before your blood draw
  • This test has been recently approved by the FDA so this might be why your healthcare provider has not yet heard of it. You can share the patient intake form or Shield brochure with your healthcare provider
  • Currently, you need a healthcare provider to order this test.  At this time, Guardant Health has no providers on site that could do this for you
  • Any healthcare provider that you see routinely can order this test. This includes your OB-GYN, your cardiologist, etc. if they are registered Shield providers or would like to register for Shield

Answer these questions to see if Shield may be right for you

  • Guardant Health is not permitted to share healthcare provider information with patients or steer patients to specific providers who are using our products
  • No, it is not recommended that you draw your own blood
  • Please check if your healthcare provider can draw blood in their office or at a nearby location. You can also contact our team to have a mobile phlebotomist (a medical professional who’s trained to perform blood draws) come to you
  • No, there is no charge for the mobile blood draw to come to your location
  • Depending on your insurance coverage, you may have an out-of-pocket cost for the Shield blood test
  • Yes, you can have multiple labs drawn at once if prescribed by your healthcare provider

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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.