Shield™: A Game-Changer in Colon Cancer Screening — FDA-Approved & 100% Covered by Medicare Part B
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the U.S., yet it’s also one of the most preventable and treatable forms of cancer when discovered early. Despite this, traditional screening tests like colonoscopies and stool tests remain under-utilized because they can be invasive, uncomfortable, or inconvenient for many people.
Now, a breakthrough option has arrived — Shield™, a simple blood test from Guardant Health that’s FDA-approved for colorectal cancer screening and covered at no out-of-pocket cost under Medicare Part B. This innovation could transform the way millions of people approach colorectal cancer prevention and early detection.
What Is Shield™?
Shield™ is the first and only blood-based test approved by the U.S. Food and Drug Administration (FDA) for primary colorectal cancer screening in adults aged 45 and older who are at average risk. Unlike traditional colonoscopies or stool tests, Shield detects molecular signals associated with colorectal cancer from a routine blood draw — no prep, no devices to handle at home, and no invasive inspection required. Guardant Health Investor Relations+1
How It Works
Shield uses advanced liquid biopsy technology to identify DNA fragments in the bloodstream that may be shed by cancerous tumors. If the test detects a signal suggestive of cancer, your provider will recommend a follow-up colonoscopy to confirm and diagnose any potential abnormalities. Shield™ by Guardant Health
Clinical data from studies involving thousands of participants show that Shield can detect colorectal cancer with high sensitivity and specificity — and importantly, its performance is comparable to other non-invasive screening methods. U.S. Food and Drug Administration
Why This Matters: Barriers to Traditional Screening
Colonoscopy has long been considered the “gold standard” for colorectal cancer detection, but it requires bowel prep, sedation, and time off work — barriers that can lead many people to delay or avoid screening. Stool-based tests (like FIT or Cologuard®) are non-invasive but involve handling samples that some patients find unpleasant.
Shield offers a screening option that can be done as part of a routine doctor’s visit with a simple blood draw — something many people are already comfortable doing. This convenience helps more people complete screening, which is critical because early detection dramatically improves survival rates. Guardant Health Investor Relations
Medicare Part B Coverage: No Cost to Eligible Patients
One of the most exciting aspects of Shield is that it is covered under Medicare Part B as a preventive service with $0 out-of-pocket cost for eligible beneficiaries who receive the test through a provider that accepts Medicare assignment. This aligns Shield with other standard preventive screenings like mammograms or colonoscopies. Medicare+1
Here’s what this coverage means:
For Medicare Advantage enrollees, costs can vary depending on your specific plan, but many plans still cover Shield with low or no cost sharing. Shield™ by Guardant Health
Who Should Consider Shield?
Shield is intended for people aged 45 and older who are at average risk for colorectal cancer, meaning they do not have a personal history of CRC or precancerous polyps, inflammatory bowel disease (such as Crohn’s), or a known family history of hereditary colorectal cancer syndromes. Shield™ by Guardant Health
It is not a replacement for diagnostic colonoscopy for people with symptoms or high-risk conditions; rather, it expands preventive options for those due for routine screening. Shield™ by Guardant Health
A Step Toward Better Screening Adherence
Early evidence shows that blood-based tests like Shield may significantly improve patient adherence — meaning more people actually complete recommended screening. In real-world data, adherence rates were reported to be as high as 95% when Shield was ordered, far surpassing typical rates seen with colonoscopy and stool-based tests. Guardant Health Investor Relations
That matters — because the best screening test is the one a patient actually completes.
A Promising New Path for Early Detection
Guardant Health’s Shield blood test represents a major milestone in colorectal cancer screening. By combining FDA-approved clinical performance with Medicare Part B preventive coverage at no cost to eligible patients, Shield offers a new, convenient pathway for early detection.
For many older adults, especially those who have avoided or delayed traditional screening methods, Shield may be the nudge they need to stay on top of their colon health — and that could save lives.
Talk to your healthcare provider about whether the Shield blood test is right for you or the people you care for. Early detection matters — and now more screening options are available than ever before.
