More Blood Tests for Cancer Hit the Market

More cancers are becoming detectable through blood tests. (Dreamstime)

Key Points

About This Summary

• Exact Sciences is launching Cancerguard, a blood test to detect many cancers before symptoms appear, available in October for $690.
• Grail, Guardant Health, and Exact are entering a multi-cancer detection market, potentially worth over $25 billion in annual sales.
• Multi-cancer blood tests face hurdles, needing FDA approval and Medicare coverage, which require large clinical trials to prove they save lives.

Exact Sciences launched a blood test Wednesday that can detect many kinds of cancer, even before symptoms appear. It will become available from its website in October for $690.

Best known for the widely advertised colon cancer test Cologuard, Exact is entering a multi-cancer detection market pioneered four years ago by the start-up Grail. A third company, Guardant Health, plans to offer such tests, too. Wide use could be just a few years away.

The tests look for bits of altered DNA that cancer cells shed into the bloodstream. The screening technology holds hope of finding cancers early, when they might be cured—including the 80% of deadly cancers for which there’s no current screen. If multi-cancer tests become routine for hundreds of millions of people, companies like Grail and Exact could be competing for more than $25 billion in annual sales.

To get there, however, the tests will need to get covered by Medicare and private insurers. Wide coverage must wait on approval by the U.S. Food and Drug Administration. And approval demands big, expensive clinical trials to show that the new technology can save lives. Meanwhile, Grail and Exact can market their products under an exemption for tests developed in-house by medical laboratories.

A pure play on multi-cancer blood tests, Grail is also closest to completing an FDA application for its test, known as Galleri. Grail stock has more than doubled this year to a recent $38.65, ahead of study data that Grail will report at the Oct. 17 meeting in Berlin of the European Society for Medical Oncology. The company has said only that its Pathfinder 2 study found “substantially higher” predictive performance for Galleri among 25,000 adults over age 50 than did an earlier 6,600-person study.

To complete its FDA submission, Grail will package the Pathfinder 2 data with results expected by mid-2026 from a 140,000-person British study. Agency deliberations could take another year. If Galleri gets approved, then the Medicare program can consider it for coverage.

Meanwhile, most who try these multicancer tests will be paying out of their own pockets. Grail’s test revenue grew 23% in the half of 2025 to $64 million. About 60% of its customers paid themselves for the Galleri test, which lists for $950. Pioneering is expensive, and Grail ended June with about $600 million in cash, after negative cash flow of $172 million for the six months.

Exact will launch its Cancerguard test with the help of the large sales force that already calls on doctors to promote Cologuard and its other products. The Cancerguard workflow entails a blood test, which will come back from the lab with a positive or negative finding of cancer somewhere in the body. A positive result should be followed up by a CT-scan or PET-scan to confirm and locate any cancer. By comparison, Grail’s Galleri blood test identifies the tissue where the cancer DNA originated, with about 90% accuracy.

Guardant got FDA approval last year for its Shield blood test for colorectal cancer, which produced sales of $15 million in the June quarter. As Guardant completes studies for lung and other kinds of cancer, it will add those to the blood test. Meanwhile, a multi-cancer version of Shield is part of a 24,000-patient study by the National Cancer Institute.

All three multi-cancer blood tests make roughly similar claims for their sensitivity in detecting cancer and avoiding false positives. In July, Grail scientists prepared for the coming competition with a report that cautioned against superficial comparisons. They correctly note that Grail has the only multi-cancer test whose data come from large, prospectively controlled groups in the general population. So far, Exact and Guardant have data from smaller, retrospective matching of the outcomes of tested people against the outcomes of untested patients.

Competition aside, the growing activity in multi-cancer testing could improve the chances that Medicare coverage is forced by congressional legislation—as it was, long ago, for colonoscopies.

At Morgan Stanley’s healthcare conference on Tuesday, Grail CEO Bob Ragusa said that some 700 advocacy groups are pushing Congress to cover multicancer blood screens. “It’s the third most co-sponsored bill in the Congress,” Ragusa said, “and it’s the number one most co-sponsored bill in healthcare.”