A single blood draw that can screen for dozens of cancers at once is moving closer to reality in the United States. The Food and Drug Administration is evaluating a test called Galleri, made by the company Grail, that can look for markers of up to 50 different cancers in one vial of blood, and the agency could approve it around the end of the year, according to NPR. If that happens, it would be the first blood test of its kind cleared through the FDA’s more rigorous approval process, potentially reshaping how routine cancer screening works.
Why this could change cancer screening
Today, most cancer screening in the U.S. targets one cancer at a time. It is common to screen for five cancers, breast, colon, cervical, prostate and lung, and each requires its own procedure, whether that is a mammogram, a colonoscopy, a Pap smear, a blood test or a CT scan. Many cancers have no routine screening test at all, which means they are often caught only after symptoms appear and the disease has advanced.
Multi-cancer early detection tests, known as MCED tests, aim to change that math. Instead of screening for individual cancers separately, they attempt to detect small amounts of tumor DNA or other cancer markers circulating in the blood, flagging a possible cancer and even predicting where in the body it may have originated. One expert quoted by NPR called it a fundamental shift in how cancer screening is approached. The appeal for an older population, which carries the highest cancer risk, is a screening tool that is simpler and broader than the current patchwork.
Where the tests stand with regulators
Galleri and a competing test called Cancerguard, now offered by Abbott after its acquisition of Exact Sciences, can already be ordered in the U.S. under a special FDA designation, but a more rigorous approval is needed before insurers and Medicare will cover them. Grail has submitted a premarket approval application for Galleri, and the FDA has been evaluating it as a breakthrough device. Full approval later in the year would clear the way for the test to become more broadly available.
Cost and coverage are central to how widely these tests would actually be used. Grail lists a retail price of $950 for Galleri, while Cancerguard is priced at $659, and it is not yet known what the companies would charge commercial insurers if full approval comes through. On the public side, Congress voted as part of a spending package to allow Medicare to reimburse multi-cancer detection tests starting in 2028, contingent on the tests clearing the tougher FDA review first.
The trial evidence is still developing and comes with caveats. Grail is running two large population studies of people over 50: one involving more than 142,000 patients in the U.K. through the National Health Service, and another, called Pathfinder 2, involving 35,000 patients in North America. The company disclosed that the NHS study did not meet a primary goal of significantly reducing the incidence of Stage 3 and 4 cancers over time. Grail has argued that, taken together, the studies show a promising trend, citing a 26% reduction in Stage IV cancers in the third year alone across cancers including pancreatic, liver, lung and gastric.
What it means for readers and what remains unknown
An important point for anyone hopeful about these tests is what they are not. Grail’s own medical advisor told NPR that Galleri is not a diagnostic tool; a positive result does not mean a person has cancer, and any signal still requires follow-up imaging or biopsy to confirm. The companies and the legislation that may eventually fund Medicare coverage both specify that these tests should be used alongside existing screening, not as a replacement for mammograms, colonoscopies and the rest.
That distinction matters because a screening test that flags possible cancer can also produce false alarms, leading to additional scans, anxiety and procedures, or can miss cancers that are present. The mixed trial results, including the NHS study falling short of its primary endpoint, are a reminder that the ability to detect DNA fragments in blood does not automatically translate into saving more lives, which is the outcome that ultimately matters.
For now, the practical situation is that these tests exist but are not yet fully approved or broadly covered, and the science on whether they reduce cancer deaths is still maturing. Readers curious about multi-cancer blood tests should discuss with their doctor whether such a test fits their personal risk, keep up with recommended screenings in the meantime, and watch for the FDA’s decision, which is the near-term milestone that will determine how quickly this technology moves from a promising idea into everyday medicine.
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*This article was researched with the help of AI, with human editors creating the final content.
