Cancer blood tests in 2026: what Galleri, Shield and liquid biopsy can and cannot do
A single blood draw that looks for dozens of cancers sounds like the end of screening as we know it. The evidence says it is a useful addition, not a replacement.
- Shield (Guardant, July 2024) and SimpleScreen CRC (Freenome and Abbott, July 2026) are FDA-approved blood tests for colorectal cancer screening from age 45.
- An FDA advisory panel voted in favour of GRAIL's Galleri multi-cancer test on 23 September 2026; the FDA's final decision is pending.
- The 142,000-person NHS-Galleri trial did not significantly reduce combined stage III and IV cancers, although fewer stage IV cancers were reported.
- These tests rarely give false alarms but miss many early cancers and almost all pre-cancerous polyps. They do not replace colonoscopy, mammography or smear tests.
- Multi-cancer tests are self-pay: about $949 for Galleri and $689 for Cancerguard in the US. They are not offered through public screening in the UK, EU or Turkey.
How a blood test can find a tumour
Cells throughout the body constantly die and release small fragments of DNA into the bloodstream. When a tumour is present, some of those fragments come from cancer cells. This is called circulating tumour DNA. A liquid biopsy tries to find that faint signal against a much larger background of normal DNA.
Tests use several kinds of clues:
- Methylation patterns: chemical tags on DNA that differ between cancer and normal cells, and also reveal which organ the DNA came from. Galleri relies mainly on this.
- Mutations: cancer-related changes in genes such as KRAS or TP53.
- Fragment patterns: cancer DNA breaks into pieces of different lengths. DELFI's FirstLook Lung uses this approach with machine learning.
- Proteins: some tests, such as Cancerguard, combine DNA signals with known blood markers like CA-125 and CEA.
Machine learning is what makes this workable. Each sample produces an enormous amount of data, and algorithms trained on thousands of patients separate cancer signals from noise, including age-related blood cell mutations that can otherwise cause false alarms.
The key limitation: small tumours shed little DNA
The amount of tumour DNA in the blood rises with the size and aggressiveness of the cancer. Large, advanced cancers are found reliably. Small stage I cancers, which are the most curable, often shed too little DNA to detect. This single fact explains most of the results below.
Which tests exist and where they stand
| Test (company) | Cancers | US status | EU / UK / Turkey |
|---|---|---|---|
| Shield (Guardant Health) | Colorectal | FDA-approved, July 2024, average-risk adults 45+ | Not approved for population screening |
| SimpleScreen CRC (Freenome, sold by Abbott) | Colorectal | FDA-approved, July 2026 | No official data |
| Galleri (GRAIL) | More than 50 cancer types | Sold as a lab-developed test; FDA panel voted in favour on 23 Sept 2026, decision pending | Not approved for screening; available privately in the UK |
| Cancerguard (Exact Sciences) | Multiple cancers | Lab-developed test, launched September 2025; not FDA-reviewed | No official data |
| FirstLook Lung (DELFI) | Lung, in people eligible for lung screening | Lab-developed test | No official data |
What the evidence shows
Colorectal blood tests
In the ECLIPSE study of about 7,900 people published in the New England Journal of Medicine in 2024, Shield detected 83% of colorectal cancers compared with colonoscopy, with about 90% specificity. But it found only 13% of advanced pre-cancerous polyps. SimpleScreen showed a similar pattern in its PREEMPT CRC study. Colonoscopy can find and remove nearly all such polyps, and stool DNA tests detect more of them than blood tests do.
Galleri in the PATHFINDER 2 study
Results presented at ESMO in October 2025, from more than 23,000 people aged 50 and over, showed very few false positives (specificity 99.6%). About six in ten positive results turned out to be cancer, and the test predicted the organ of origin correctly in about 92% of cases. Overall it detected roughly 40% of cancers diagnosed within a year, and much more of the most deadly types than of slow-growing ones. The FDA's own analysis gave a somewhat lower sensitivity and noted that the true figure is uncertain.
The NHS-Galleri trial
This randomised trial in England enrolled about 142,000 people aged 50 to 77, who gave blood once a year for three years. Full results were presented at ASCO in June 2026. The trial did not significantly reduce the main target, the number of cancers diagnosed at stage III or IV combined. GRAIL highlighted a reduction in stage IV diagnoses as a secondary finding. Whether the test saves lives will depend on longer follow-up.
Cost and access
- United States: Medicare covers Shield for eligible average-risk adults. Galleri costs about $949 and Cancerguard $689, both self-pay, though eligible for health savings accounts. A 2026 US law created a route for Medicare to cover multi-cancer tests once they are FDA-approved, but not immediately.
- United Kingdom: the NHS does not provide Galleri outside research; private clinics sell it. Bowel screening on the NHS uses stool tests (FIT).
- European Union: no multi-cancer blood test is certified for population screening under the EU diagnostics regulation (IVDR). Access is limited to private clinics.
- Turkey: we found no screening blood test approved by the medicines agency (TİTCK) or reimbursed by SGK. Private oncology centres use liquid biopsy mainly to choose treatment for people already diagnosed with advanced cancer.
Risks you should know about
- False alarms lead to investigations. Even with 99.5% specificity, testing 100,000 healthy people produces several hundred false positives, each followed by scans, endoscopies or biopsies.
- False reassurance. The biggest danger is skipping colonoscopy, mammography or smear tests because a blood test was negative.
- Overdiagnosis. Some slow-growing cancers found by testing would never have caused harm, but may still be treated.
- No proven survival benefit yet. Finding cancer earlier does not automatically mean living longer. Mortality data from randomised trials is still awaited.
Trials to watch
- NHS-Galleri (NCT05611632): ongoing follow-up of cancer deaths.
- US National Cancer Institute Vanguard Study: a feasibility trial of about 24,000 people, preparing a much larger trial to test whether multi-cancer screening reduces deaths.
- CRANE: Exact Sciences' real-world study of Cancerguard.
- FIND-CRC (Natera): another colorectal blood test aiming for FDA submission.
Questions patients ask
Can a blood test replace my colonoscopy or mammogram?
No. Blood tests miss most pre-cancerous polyps and many early cancers. Guidelines and the test makers say they should be used alongside standard screening, not instead of it.
If the result is negative, am I cancer-free?
Not necessarily. A negative result means no cancer signal was detected in that sample. Small early cancers often release too little DNA to be found.
What happens after a positive result?
Your doctor will arrange scans and often a biopsy. Galleri also predicts the likely organ of origin, which helps target the investigation.
Why did the NHS-Galleri trial get mixed reactions?
It missed its main goal of reducing combined stage III and IV cancers, but reported fewer stage IV cancers as a secondary result. Experts disagree on how to weigh this, and long-term mortality data is still to come.
Which cancers do these tests find best?
Aggressive internal cancers that shed more DNA, such as pancreatic, liver, ovarian and oesophageal cancers. They are weaker for early breast and prostate cancer.
Can I get a multi-cancer blood test in Turkey or the EU?
We found no approval for population screening in Turkey or the EU. Some private clinics in Europe offer them for self-payment; in Turkey, liquid biopsy is mainly used for treatment decisions in diagnosed cancer.
- FDA premarket approval P230009 (Shield), July 2024. https://www.fda.gov/medical-devices/recently-approved-devices/shield-p230009
- A cell-free DNA blood-based test for colorectal cancer screening (ECLIPSE), NEJM, March 2024. https://pubmed.ncbi.nlm.nih.gov/38477985/
- FDA approves SimpleScreen CRC blood-based screening test, ASCO Post, July 2026. https://ascopost.com/news/july-2026/fda-approves-simplescreen-crc-blood-based-screening-test-for-colorectal-cancer/
- FDA approves Freenome's SimpleScreen, Freenome. https://www.freenome.com/newsroom/fda-approves-freenomes-simplescreen
- September 23, 2026 Molecular and Clinical Genetics Panel meeting, FDA. https://www.fda.gov/advisory-committees/advisory-committee-calendar/september-23-2026-molecular-and-clinical-genetics-panel-medical-devices-advisory-committee-meeting
- FDA advisory committee votes in favor of approval of Galleri, GRAIL. https://grail.com/press-releases/fda-advisory-committee-votes-in-favor-of-approval-of-grails-galleri-multi-cancer-early-detection-test/
- FDA executive summary: Galleri, September 2026. https://www.fda.gov/media/194909/download
- GRAIL reports full results from NHS-Galleri trial at ASCO 2026. https://grail.com/press-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting/
- NHS-Galleri trial finds no significant reduction in stage III or IV cancer, HMP Global. https://www.hmpgloballearningnetwork.com/site/onc/news/nhs-galleri-trial-finds-no-significant-reduction-stage-iii-or-iv-cancer-multicancer
- PATHFINDER 2 initial results, ESMO 2025 (OncologyPRO). https://oncologypro.esmo.org/video-series/pathfinder-2-multi-cancer-early-detection-test-in-an-intended-use-population
- Exact Sciences launches Cancerguard, September 2025. https://www.exactsciences.com/news-events/press-releases/exact-sciences-launches-cancerguard-first-of-its-kind-multi-cancer-early-detection-blood-test
- Clinical validation of a cfDNA fragmentome assay for lung cancer, Cancer Discovery, June 2024. https://www.prnewswire.com/news-releases/landmark-blood-based-ai-lung-cancer-screening-test-study-results-published-in-cancer-discovery-302162028.html
- Galleri blood test, Cancer Research UK. https://www.cancerresearchuk.org/about-cancer/tests-and-scans/blood-tests/galleri-blood-test
- NIH launches research network to evaluate emerging cancer screening technologies. https://www.nih.gov/news-events/news-releases/nih-launches-research-network-evaluate-emerging-cancer-screening-technologies
- Multi-cancer early detection FAQs, Prevent Cancer Foundation. https://preventcancer.org/policy-advocacy/multi-cancer-early-detection/frequently-asked-questions/