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The first FDA-approved blood test for colorectal cancer screening (2024), now optionally reporting other cancers too.
Shield is Guardant Health's blood-based colorectal cancer screening test: it reads cell-free DNA for methylation patterns, fragmentation signatures and mutations that indicate a tumour. It was the first FDA-approved blood test for colorectal cancer screening (2024), for average-risk adults aged 45 and over with Medicare coverage. In the ECLIPSE study it detected 83% of colorectal cancers with 90% specificity, but only 13% of advanced adenomas, the precancerous lesions that colonoscopy removes to prevent cancer. Its value therefore lies in reaching people who decline colonoscopy or stool tests, and any positive result must be followed by colonoscopy. In 2025 a Shield MCD option added multi-cancer detection with Breakthrough designation. For a newcomer: a convenient blood test for bowel cancer that catches cancers well but polyps poorly.
cfDNA methylation, fragmentomics, and mutations.
1.Cell-free DNA is extracted from plasma
Medicare covers a blood-based colorectal cancer screening test every three years for people aged 45 to 85 at average risk when the test is FDA-approved and meets the sensitivity and specificity thresholds in NCD 210.3; Shield qualified in 2024. As a screening test it has no deductible or coinsurance.
Blood-based screening is not yet in the USPSTF recommendation, so the ACA $0 preventive mandate does not apply; some commercial plans cover Shield, others do not, and the patient may pay the cash price.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Colorectal cancer screenings · CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
Sources: NICE search: Shield blood test. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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FDA advisory committee votes favourably source
PMA approval: first blood test for primary colorectal cancer screening (ECLIPSE) source
Medicare coverage under the blood-based CRC screening NCD source
Breakthrough Device designation for Shield multi-cancer (MCD) source
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Colorectal cancer screening, average-risk adults ≥45 |
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare covers Shield every 3 years for average-risk adults 45-85 (2024 NCD); commercial coverage expanding | $1,495 list price | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Shield" OR ABSTRACT:"Shield") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Shield, not a curated reading list.
Shares Cancerguard, Cologuard Plus, Cologuard, Multitarget stool RNA test (ColoSense).
Shares SimpleScreen CRC, Freenome, Screening, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares SimpleScreen CRC, Freenome, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Liquid biopsy (ctDNA).
Shares Cologuard, Early detection roadmap: organ screening → blood tests for many cancers, Early-onset colorectal cancer (under 50), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares Cologuard, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Multi-cancer early detection (MCED), The hardest cancers are found late.
Shares SimpleScreen CRC, Freenome, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
Shares Cancerguard, Mandatory interval-cancer audit for every blood-based screening test, Early detection roadmap: organ screening → blood tests for many cancers, Screening.
Shares Cologuard Plus, Cologuard, Multitarget stool RNA test (ColoSense), Early-onset colorectal cancer (under 50).