2026-10-30 · 4 min read · healthcarewithai.com Editorial Team

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.

Blood tests that detect tumour DNA have moved from the lab into clinics. Two colon cancer blood tests are now FDA-approved, and an FDA panel backed the Galleri multi-cancer test in September 2026. But they miss most early-stage cancers and the large NHS trial missed its main goal.
Key points
  • 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:

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)CancersUS statusEU / UK / Turkey
Shield (Guardant Health)ColorectalFDA-approved, July 2024, average-risk adults 45+Not approved for population screening
SimpleScreen CRC (Freenome, sold by Abbott)ColorectalFDA-approved, July 2026No official data
Galleri (GRAIL)More than 50 cancer typesSold as a lab-developed test; FDA panel voted in favour on 23 Sept 2026, decision pendingNot approved for screening; available privately in the UK
Cancerguard (Exact Sciences)Multiple cancersLab-developed test, launched September 2025; not FDA-reviewedNo official data
FirstLook Lung (DELFI)Lung, in people eligible for lung screeningLab-developed testNo 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.

In plain words: a positive result is a strong reason to investigate; a negative result does not mean you are cancer-free.

Cost and access

Risks you should know about

Trials to watch

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.

Sources
  1. FDA premarket approval P230009 (Shield), July 2024. https://www.fda.gov/medical-devices/recently-approved-devices/shield-p230009
  2. A cell-free DNA blood-based test for colorectal cancer screening (ECLIPSE), NEJM, March 2024. https://pubmed.ncbi.nlm.nih.gov/38477985/
  3. 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/
  4. FDA approves Freenome's SimpleScreen, Freenome. https://www.freenome.com/newsroom/fda-approves-freenomes-simplescreen
  5. 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
  6. 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/
  7. FDA executive summary: Galleri, September 2026. https://www.fda.gov/media/194909/download
  8. 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/
  9. 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
  10. 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
  11. 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
  12. 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
  13. Galleri blood test, Cancer Research UK. https://www.cancerresearchuk.org/about-cancer/tests-and-scans/blood-tests/galleri-blood-test
  14. 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
  15. Multi-cancer early detection FAQs, Prevent Cancer Foundation. https://preventcancer.org/policy-advocacy/multi-cancer-early-detection/frequently-asked-questions/
This article is for information only and is not medical advice. Talk to your doctor before making any decision about your health or treatment. Approval status and prices change; check with the provider or regulator for the latest position.