FDA APPROVED FOR COLORECTAL CANCER (CRC) SCREENING

The Future of
Colon Cancer
Screening is
Here.

What if $3 million could help protect 84 million Americans?

84 million Americans are ages 45-641 – eligible for colon cancer screening but not yet qualified for Medicare. CRC screening rates remain stagnant and low with current screening modalities2. Without a ~$3 million increase in funding for the US Preventive Services Task Force (USPSTF)* these individuals could face an out-of-pocket expense for a new blood-based screening test.||

Cancer screening tests recommended by USPSTF are provided at no cost to the individual. With more funding the USPSTF can update its recommendations so that patients have access to new screening tools without delay.

The USPSTF Lacks the Resources to Keep Pace with Science

The USPSTF aims to review and update existing recommendations every five years, but science sometimes moves faster.

The Task Force is under-resourced and underfunded. With rapid developments in biomedical innovation, the current pace of USPSTF updates could limit adoption of new screening technologies.

The USPSTF Needs More Funding Now

Additional funding can help ensure there is no delay in blood-based CRC screening tests reaching the patients who need them.

The Agency for Health Care Quality and Research (AHRQ)† has repeatedly stated that with additional funding, they could support the Task Force in modifying its processes to keep up with new technologies and changing evidence. More resources could mean more reviews each year.

The President's latest Budget Proposal‡ included increased funding for USPSTF, but Congress still needs to act.

Additional Resources

Resources to Learn More

Stakeholder Letters

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.

*The USPSTF is an independent advisory body that issues evidence-based recommendations for preventive services. Cancer screenings that receive an A or B grade from the Task Force are covered with $0 cost-sharing for insured patients.

||Shield™ is an FDA-approved blood test intended to detect colorectal cancer.

Centers for Medicare and Medicaid Services (CMS) NCD 210.3, Colorectal Cancer Screening Tests, includes coverage for blood-based biomarker tests that meet certain performance characteristics

†The Agency for Health Care Quality and Research (AHRQ) provides support for the USPSTF.

‡President Biden’s Fiscal Year 2025 budget proposal included $18.0 million for AHRQ for its administration of the USPSTF, an increase of $6.5 million over the FY2024 enacted level.

  1. References:
  2. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening
  3. Centers for Disease Control and Prevention. Cost-effectiveness of colorectal cancer interventions. Updated July 11, 2024. Accessed August 5, 2024. https://www.cdc.gov/nccdphp/priorities/colorectal-cancer.html?CDC_AAref_Val=https://www.cdc.gov/chronicdisease/programs-impact/pop/colorectal-cancer.htm