Shield
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. ECLIPSE: 83% sensitivity for CRC, 13% for advanced adenomas, 90% specificity. Medicare coverage. Shield MCD (multi-cancer) option added 2025 with Breakthrough designation.
1.Cell-free DNA is extracted from plasma
- Medicare
- Part B (clinician-administered)NCD 210.3
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.
- Commercial insurance
- variable
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.
- Assistance programmes
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.
- Notes
- US-only blood-based colorectal screening test; NHS bowel screening uses the FIT stool test.
- NHS England
- Not routinely funded
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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- 23 May 2024Advisory committeeUS
FDA advisory committee votes favourably source
- 29 Jul 2024ApprovalUS
PMA approval: first blood test for primary colorectal cancer screening (ECLIPSE) source
- Aug 2024ApprovalUS
Medicare coverage under the blood-based CRC screening NCD source
- Jun 2025DesignationUS
Breakthrough Device designation for Shield multi-cancer (MCD) source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- CompanyExact Sciences (Abbott)
Shares Early detection roadmap: organ screening → blood tests for many cancers, Multi-cancer early detection (MCED), Most lethal cancers are found late, Colorectal cancer.
- ProductGalleri
Shares Mandatory interval-cancer audit for every blood-based screening test, Screening, Early detection roadmap: organ screening → blood tests for many cancers, Multi-cancer early detection (MCED).
- TechnologyBreath and volatile-organic-compound detection
Shares Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Multi-cancer early detection (MCED), Liquid biopsy (ctDNA), Colorectal cancer.
- TechnologycfDNA fragmentomics
Shares Intravasation & circulating tumour cells, Multi-cancer early detection (MCED), Most lethal cancers are found late, Liquid biopsy (ctDNA).
- PersonChadwick Boseman
Shares Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Most lethal cancers are found late, Colorectal cancer.
- IdeaCheap DNA fragment-pattern blood test as a first sieve before expensive cancer tests
Shares Multi-cancer early detection (MCED), Most lethal cancers are found late, Liquid biopsy (ctDNA).
- PersonKatie Couric
Shares Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Most lethal cancers are found late, Colorectal cancer.
- Key paperNHS-Galleri: design of the largest randomised trial of a multi-cancer blood test
Shares Early detection roadmap: organ screening → blood tests for many cancers, Multi-cancer early detection (MCED), Most lethal cancers are found late, Liquid biopsy (ctDNA).