The American Cancer Society added Guardant Health’s Shield blood test to its updated colorectal cancer screening guidelines, published May 27.
The Palo Alto, Calif.-based precision oncology company said the ACS now recommends Shield for patients who decline or have not completed stool-based or visual examination screening. The recommendation makes Shield the first and only FDA-approved blood test included in both ACS and National Comprehensive Cancer Network guidelines; the NCCN added Shield in June 2025.
The FDA approved Shield in 2024 for average-risk adults age 45 and older, and the test requires only a blood draw during a routine office visit. That positions it for the more than 50 million eligible Americans who remain unscreened. Colorectal cancer is the second-leading cancer killer in the U.S. and the leading cancer killer for adults under 50.
Reimbursement has tracked the clinical momentum. CMS granted Shield Advanced Diagnostic Laboratory Test status in 2025, setting a $1,495 Medicare rate, up from $920, with market-based pricing now in effect through 2027.
Across roughly 200,000 patients in real-world use, more than 90% completed the test, and in the pivotal ECLIPSE study Shield showed 100% sensitivity in detecting stage II and higher cancers.
“The inclusion of Shield in the American Cancer Society’s guidelines as a recommended option is a momentous step forward,” said AmirAli Talasaz, Guardant Health co-CEO.
The ACS last updated its colorectal cancer screening guidelines in 2018, when it lowered the recommended screening age for average-risk adults from 50 to 45.
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