Explainer
Home and blood cancer screening tests: FIT vs Cologuard vs Shield
For colorectal cancer, a FIT stool test gives fewer false positives. In the BLUE-C study the Cologuard Plus stool DNA test found more cancers (93.9% vs 67.3%) but had lower specificity.[1][2] FDA-approved blood tests (Shield, SimpleScreen) detect about 8 in 10 cancers but few precancers.[3][4] Galleri, a multi-cancer blood test, was not FDA-approved as of 11 October 2026.[5]
Several cancer screening tests can now be done with a home stool kit or a blood draw instead of a procedure. This guide compares the main options for colorectal cancer, plus the Galleri multi-cancer blood test, using published study results, regulatory status and maker-stated prices. Figures are as of 11 October 2026.
How this guide works: ContentLora does no hands-on testing. We did not take or order any of these tests. We compare peer-reviewed accuracy data, FDA status and labelling, and published prices, and cite every figure. Most studies below were funded by the test’s maker, which we note.
This guide is not medical advice. Which test suits you depends on your age, risk and history. Talk to a clinician, and if you have symptoms such as bleeding or a change in bowel habits, see a doctor rather than ordering a screening test (see cancer warning signs).
Colorectal tests at a glance
- FIT (faecal immunochemical test) checks a stool sample for hidden blood. It is the test the NHS posts to people aged 50 to 74 every two years.[6][7] The USPSTF lists yearly FIT as one recommended option.[8]
- Stool DNA-FIT (Cologuard Plus) looks for blood and DNA changes in stool. The USPSTF lists stool DNA-FIT every 1 to 3 years.[8]
- Blood tests (Shield, SimpleScreen) look for tumour DNA in a blood sample. They are FDA-approved but are not part of the 2021 USPSTF recommendation.[9][4][10]
Any positive result from these tests needs a colonoscopy.[11][9]
| Test | Type | Cancer sensitivity | Advanced precancer sensitivity | Specificity (advanced neoplasia) | Study (funder) |
|---|---|---|---|---|---|
| FIT (commercial) | Stool, blood | 67.3% | 23.3% | 94.8% | BLUE-C comparator (Exact Sciences)[2] |
| Cologuard Plus | Stool, DNA + blood | 93.9% | 43.4% | 90.6% | BLUE-C, 20,176 people (Exact Sciences)[1] |
| Shield | Blood, cell-free DNA | 83.1% | 13.2% | 89.6% | ECLIPSE, 7,861 evaluable (Guardant Health)[3] |
| SimpleScreen CRC | Blood, cell-free DNA | 81.1% | 13.7% | 90.4% | PREEMPT CRC (maker-reported)[4] |
FIT and Cologuard Plus were measured head to head in the same people. The blood tests come from separate studies with different populations, so cross-study comparisons are approximate.[2][3][4]
The trade-offs
- Finding cancer vs false alarms. In BLUE-C, Cologuard Plus found more cancers and precancers than FIT but had lower specificity, so more people without advanced disease would be sent for colonoscopy.[2]
- Precancers. Stool tests detected more advanced precancerous lesions than the blood tests in their studies (23.3% to 43.4% versus about 13%).[1][2][3] Shield’s labelling says it detects 55% to 65% of stage I cancers and does not detect 87% of precancerous lesions.[9]
- Convenience. A blood draw needs no stool handling. A PREEMPT CRC investigator, quoted by Freenome, said a blood test offers another way to reach people who are not being screened.[4]
FDA status and prices (as of 11 October 2026)
| Test | FDA status | Price information |
|---|---|---|
| FIT | Used in the NHS bowel screening programme; kit posted to eligible people aged 50–74 in England[7] | Not compared here |
| Cologuard Plus | FDA-approved; prescribed, adults 45+ at average risk[12] | Maker says “most people pay $0”; no list price stated[12] |
| Shield | FDA-approved in 2024, adults 45+ at average risk[9] | $1,495 cash-pay rate, effective 1 Aug 2024[13] |
| SimpleScreen CRC | FDA-approved 27 July 2026; Abbott to sell it in the US from autumn 2026[4] | Not stated in the approval announcement |
| Galleri (multi-cancer) | Not FDA-cleared or approved; PMA under review[5] | Not broadly reimbursed as of mid-2026[14] |
Abbott now owns both Cologuard and the US rights to SimpleScreen.[12][4] Guardant also offers a Shield multi-cancer results report, which is not part of the FDA-approved test and has not been cleared or approved by the FDA.[15]
Multi-cancer blood tests
Galleri screens for more than 50 cancer types from one blood sample.[16] In the randomised NHS-Galleri trial it detected 26.7% to 37.2% of cancers diagnosed within a year across rounds, with specificity of about 99.5%.[17] GRAIL says it should be used alongside routine screening, not instead of it.[18] Whether it improves outcomes is debated; see our analysis of multi-cancer early detection.
Who might consider what
These are summaries of what guidelines and labels say, not recommendations for any individual.
- Average-risk adults 45 to 75 choosing a colorectal test: the USPSTF lists FIT yearly, stool DNA-FIT every 1 to 3 years, and visual tests including colonoscopy every 10 years as acceptable.[8]
- People who will not do a stool test or colonoscopy: FDA-approved blood tests are an option under their labels, with the trade-off of low precancer detection.[9][4]
- People at higher risk (for example, a family history or inflammatory bowel disease) fall outside the average-risk labels. Shield’s labelling excludes them. Ask a clinician.[9]
For screening ages and intervals across all cancers, see the cancer screening explainer.
Read next
Next in the crash course
Multi-cancer blood tests: what NHS-Galleri showed and the FDA debate
NHS-Galleri missed its main goal but cut stage IV cancers. What the trial data show about multi-cancer blood tests and the views ahead of an FDA decision.
Questions readers ask
Is Cologuard better than FIT?
In the BLUE-C study, Cologuard Plus detected 93.9% of colorectal cancers versus 67.3% for FIT, and 43.4% versus 23.3% of advanced precancerous lesions. FIT had higher specificity (94.8% vs 90.6%), meaning fewer false positives.[1][2]
Can a blood test replace a colonoscopy?
No. Shield's labelling says positive results should be followed by colonoscopy and that it does not detect 87% of precancerous lesions. The USPSTF's 2021 recommendation does not include blood tests.[9][10]
How much does the Shield blood test cost?
Guardant Health set a cash-pay rate of $1,495, effective 1 August 2024, for people whose insurance does not fully cover the test.[13]
Sources
· 19 claims from 12 publishers
Each numbered claim is a statement we checked against the sources listed with it. Tap a number in the text to see its sources in place.
- [1]
In the BLUE-C study (20,176 participants, funded by Exact Sciences), the next-generation multitarget stool DNA test (Cologuard Plus) had 93.9% sensitivity for colorectal cancer, 43.4% for advanced precancerous lesions, and 90.6% specificity for advanced neoplasia. confirmedas of 2026-10-11
- Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening (BLUE-C) · The New England Journal of Medicine · 2024-03-14 · Results (retrieved 2026-10-11)
- Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening (BLUE-C) · The New England Journal of Medicine · 2024-03-14 · Results (retrieved 2026-10-11)
- Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening (BLUE-C) · The New England Journal of Medicine · 2024-03-14 · Funding (retrieved 2026-10-11)
- [2]
In the same BLUE-C study, a commercial FIT had 67.3% sensitivity for colorectal cancer, 23.3% for advanced precancerous lesions, and 94.8% specificity for advanced neoplasia, so it missed more cancers but gave fewer false positives than the stool DNA test. confirmedas of 2026-10-11
- Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening (BLUE-C) · The New England Journal of Medicine · 2024-03-14 · Results (retrieved 2026-10-11)
- Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening (BLUE-C) · The New England Journal of Medicine · 2024-03-14 · Conclusions (retrieved 2026-10-11)
- [3]
In the ECLIPSE study (7,861 evaluable participants, funded by Guardant Health), the Shield cell-free DNA blood test had 83.1% sensitivity for colorectal cancer, 13.2% for advanced precancerous lesions, and 89.6% specificity for advanced neoplasia. confirmedas of 2026-10-11
- A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening (ECLIPSE) · The New England Journal of Medicine · 2024-03-14 · Results (retrieved 2026-10-11)
- A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening (ECLIPSE) · The New England Journal of Medicine · 2024-03-14 · Results (retrieved 2026-10-11)
- A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening (ECLIPSE) · The New England Journal of Medicine · 2024-03-14 · Results (retrieved 2026-10-11)
- A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening (ECLIPSE) · The New England Journal of Medicine · 2024-03-14 · Funding (retrieved 2026-10-11)
- [4]
On 27 July 2026 the FDA approved Freenome's SimpleScreen CRC blood test for average-risk adults 45 and older; in the PREEMPT CRC study it detected 81.1% of colorectal cancers and 13.7% of advanced precancerous lesions, with 90.4% specificity, and Abbott will sell it in the US. A study investigator quoted by Freenome said a blood test offers another way to reach unscreened patients. confirmedas of 2026-07-27
- FDA Approves Freenome's SimpleScreen CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S. · Freenome and Abbott · 2026-07-27 · Paragraph 5 (retrieved 2026-10-11)
- FDA Approves Freenome's SimpleScreen CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S. · Freenome and Abbott · 2026-07-27 · Paragraph 1 (retrieved 2026-10-11)
- FDA Approves Freenome's SimpleScreen CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S. · Freenome and Abbott · 2026-07-27 · Quote from Aasma Shaukat (retrieved 2026-10-11)
- Colorectal cancer: FDA-approved 2nd blood test can close screening gap · Medical News Today · 2026-07-29 · Body (retrieved 2026-10-11)
- [5]
As of 11 October 2026 Galleri's own site stated that the test has not been cleared or approved by the FDA; it is sold as a laboratory-developed test under CLIA and requires a prescription. confirmedas of 2026-10-11
- Galleri patient site (pricing and billing page, safety and laboratory information) · GRAIL (Galleri.com) · Laboratory/Test Information (retrieved 2026-10-11)
- Galleri patient site (pricing and billing page, safety and laboratory information) · GRAIL (Galleri.com) · Laboratory/Test Information (retrieved 2026-10-11)
- FDA Advisory Committee Votes In Favor of Approval of GRAIL's Galleri Multi-Cancer Early Detection Test · GRAIL · 2026-09-23 · Body (retrieved 2026-10-11)
- [6]
NHS bowel screening uses a faecal immunochemical test (FIT) done at home and posted back; a result showing blood usually leads to a colonoscopy, and a normal result does not rule out bowel cancer. confirmedas of 2026-10-11
- Bowel cancer screening · NHS · Why bowel cancer screening is done (retrieved 2026-10-11)
- Bowel cancer screening · NHS · Further tests needed (retrieved 2026-10-11)
- Bowel cancer screening · NHS · No further tests needed (retrieved 2026-10-11)
- [7]
In England the NHS offers cervical screening every 5 years at ages 25 to 64, breast screening at 50 to 70 (self-referral over 70), and a home bowel test kit every 2 years at 50 to 74. confirmedas of 2026-10-11
- NHS screening · NHS · Cervical screening (retrieved 2026-10-11)
- NHS screening · NHS · Breast screening (retrieved 2026-10-11)
- NHS screening · NHS · Bowel cancer screening (retrieved 2026-10-11)
- [8]
The USPSTF's recommended colorectal screening strategies include FIT or high-sensitivity guaiac stool testing every year, stool DNA-FIT every 1 to 3 years, CT colonography or flexible sigmoidoscopy every 5 years, and colonoscopy every 10 years. confirmedas of 2026-10-11
- Colorectal Cancer: Screening (final recommendation statement, May 18, 2021) · US Preventive Services Task Force · 2021-05-18 · Clinician Summary (retrieved 2026-10-11)
- [9]
Shield is FDA-approved for colorectal cancer screening in average-risk adults 45 and older; positive results should be followed by colonoscopy, its labelling says it has limited detection (55% to 65%) of stage I cancer and does not detect 87% of precancerous lesions, and it is not indicated for people at high risk, such as those with inflammatory bowel disease or a family history of colorectal cancer. confirmedas of 2026-10-11
- Shield Blood Test (product site, important product information and cost) · Guardant Health · Intended Use (retrieved 2026-10-11)
- Shield Blood Test (product site, important product information and cost) · Guardant Health · Precaution (retrieved 2026-10-11)
- Shield Blood Test (product site, important product information and cost) · Guardant Health · Limitations and Other Important Information (retrieved 2026-10-11)
- Colorectal cancer: FDA-approved 2nd blood test can close screening gap · Medical News Today · 2026-07-29 · Body (retrieved 2026-10-11)
- [10]
The 2021 USPSTF colorectal recommendation does not include blood (serum) tests, urine tests or capsule endoscopy because of limited evidence. confirmedas of 2026-10-11
- Colorectal Cancer: Screening (final recommendation statement, May 18, 2021) · US Preventive Services Task Force · 2021-05-18 · Recommendation rationale (retrieved 2026-10-11)
- [11]
Under the USPSTF recommendation, an abnormal stool-based test result needs follow-up colonoscopy. confirmedas of 2026-10-11
- Colorectal Cancer: Screening (final recommendation statement, May 18, 2021) · US Preventive Services Task Force · 2021-05-18 · Practice Considerations (retrieved 2026-10-11)
- [12]
Cologuard Plus, an FDA-approved next-generation version of Cologuard now owned by Abbott, is a prescribed home stool DNA test for average-risk adults 45 and older; its maker says most people pay $0. confirmedas of 2026-10-11
- Cologuard Plus patient site · Exact Sciences (Abbott) · What is the Cologuard Plus test? (retrieved 2026-10-11)
- Cologuard Plus patient site · Exact Sciences (Abbott) · Home page (asterisked) (retrieved 2026-10-11)
- Cologuard Plus patient site · Exact Sciences (Abbott) · Footer (retrieved 2026-10-11)
- Cologuard Plus patient site · Exact Sciences (Abbott) · FAQ (retrieved 2026-10-11)
- [13]
Guardant Health set a cash-pay rate of $1,495 for the Shield test, effective 1 August 2024, for cases where insurance does not fully cover it. confirmedas of 2026-10-11
- Shield Blood Test (product site, important product information and cost) · Guardant Health · Cost (retrieved 2026-10-11)
- [14]
GRAIL launched Galleri in the US in mid-2021; as of mid-2026 it was not broadly reimbursed, and FDA approval was not required to market it. confirmedas of 2026-08-06
- GRAIL, Inc. Form 10-Q for the quarter ended June 30, 2026 · GRAIL (SEC filing) · 2026-08-06 · Business overview (retrieved 2026-10-11)
- GRAIL, Inc. Form 10-Q for the quarter ended June 30, 2026 · GRAIL (SEC filing) · 2026-08-06 · MD&A (retrieved 2026-10-11)
- GRAIL, Inc. Form 10-Q for the quarter ended June 30, 2026 · GRAIL (SEC filing) · 2026-08-06 · Regulatory (retrieved 2026-10-11)
- [15]
Guardant's Shield multi-cancer detection (MCD) results report is not part of the FDA-approved Shield test and has not been cleared or approved by the FDA. confirmedas of 2026-10-11
- Shield Blood Test (product site, important product information and cost) · Guardant Health · Performance by cancer type (retrieved 2026-10-11)
- [16]
Galleri is a prescription blood test that looks for cancer-specific DNA methylation patterns in cell-free DNA, screens for more than 50 cancer types, and predicts where in the body a cancer signal originated. confirmedas of 2026-10-11
- GRAIL, Inc. Form 10-Q for the quarter ended June 30, 2026 · GRAIL (SEC filing) · 2026-08-06 · Business overview (retrieved 2026-10-11)
- GRAIL Reports Full Results From NHS-Galleri Trial Demonstrating Substantial Reduction in Stage IV Cancer Diagnoses at 2026 ASCO Annual Meeting · GRAIL · 2026-05-30 · About Galleri (retrieved 2026-10-11)
- [17]
Across NHS-Galleri's three rounds, specificity was 99.50% to 99.60%, positive predictive value fell from 58.0% to 45.8%, and episode sensitivity was 26.7% to 37.2% for all cancers and 47.6% to 63.4% for the 12 prespecified types. confirmedas of 2026-10-11
- Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial · Nature Medicine · 2026-09-22 · Abstract (retrieved 2026-10-11)
- Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial · Nature Medicine · 2026-09-22 · Abstract (retrieved 2026-10-11)
- [18]
GRAIL says Galleri should be used in addition to routine screening, a negative result does not rule out cancer, a positive result needs diagnostic confirmation, and it is not recommended in pregnancy, at age 21 or younger, or during active cancer treatment. confirmedas of 2026-10-11
- Galleri patient site (pricing and billing page, safety and laboratory information) · GRAIL (Galleri.com) · Important Safety Information (retrieved 2026-10-11)
- Galleri patient site (pricing and billing page, safety and laboratory information) · GRAIL (Galleri.com) · Important Safety Information (retrieved 2026-10-11)
- Galleri patient site (pricing and billing page, safety and laboratory information) · GRAIL (Galleri.com) · Important Safety Information (retrieved 2026-10-11)
- [19]
On 23 September 2026 an FDA advisory panel voted 7-2 with one abstention that Galleri's benefits outweigh its risks, unanimously on safety, and 6-4 on effectiveness, for screening adults aged 50 and older; the FDA is not bound by the vote. confirmedas of 2026-09-23
- FDA Advisory Committee Votes In Favor of Approval of GRAIL's Galleri Multi-Cancer Early Detection Test · GRAIL · 2026-09-23 · Paragraph 2 (retrieved 2026-10-11)
- FDA Advisory Committee Votes in Favor of Approval of Multi-Cancer Early Detection Test · The ASCO Post · 2026-09-24 · Body (retrieved 2026-10-11)
Revision history (1)
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Created Oct 11, 2026. Last reviewed by an editor on Oct 11, 2026. Next scheduled review: Jan 11, 2027.
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"Home and blood cancer screening tests: FIT vs Cologuard vs Shield." ContentLora, updated Oct 11, 2026. https://contentlora.com/explain/at-home-cancer-screening-tests-buyers-guide
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