Grail’s cancer blood test nears FDA approval

By the Editorial Team · Monday, October 5, 2026

An FDA advisory panel recommended approval of Grail’s Galleri blood test for early cancer detection, clearing a major hurdle toward formal authorization. If approved, Galleri could become the first multi-cancer screening blood test covered by Medicare by 2028, potentially transforming cancer diagnosis and expanding the market to billions annually.

An advisory panel to the U.S. Food and Drug Administration (FDA) recommended approval in September for Grail’s Galleri blood test, designed for early cancer detection. The panel concluded that the test's potential benefits outweigh its risks, marking a significant step toward FDA authorization. Although the FDA is not obligated to follow the panel’s guidance, analysts anticipate the agency will approve the test within the coming months.

If authorized, Galleri could become the first FDA-approved multi-cancer early detection blood test, a development experts say is crucial for securing insurance coverage. Currently, Galleri and Abbott’s Cancerguard tests are offered in the United States as laboratory-developed tests under the Clinical Laboratory Improvement Amendments (CLIA) but lack Medicare coverage. As a result, patients pay out-of-pocket costs of approximately $700 for Galleri and $900 for Cancerguard.

FDA approval is expected to enable coverage under Medicare starting in 2028, pursuant to recent federal legislation. Private insurers would likely follow suit if the U.S. Preventive Services Task Force issues a recommendation supporting the tests. Several major health insurers—including CVS Health, Humana, UnitedHealth Group, Cigna, and Centene—either declined to comment or did not respond to inquiries regarding potential coverage.

Market analysts project significant growth in cancer blood testing if coverage expands. Elena Meng, a portfolio manager and research analyst at Gabelli Funds, estimates the U.S. market could reach $60 billion annually by 2030, based on 120 million adults aged 50 and older taking a $500 test each year. Globally, the market could expand to $150 billion. Meng anticipates that between 30% and 50% of the eligible U.S. population might adopt such testing over five to ten years, corresponding to a $18 billion to $30 billion market size domestically.

Currently, established preventive cancer screening guidelines in the United States apply to five cancers: breast, cervical, colorectal, prostate, and lung cancer. Among these, prostate cancer is the only one routinely screened via a blood test; the others rely on imaging, cytology, stool-based tests, or low-dose computed tomography scans.

The potential approval and subsequent insurance coverage of multi-cancer early detection tests like Galleri could mark a significant shift in cancer screening approaches, offering a less invasive alternative to traditional methods and potentially improving early diagnosis rates.

This article was reported by synthesizing coverage from multiple independent news outlets to present a balanced, unbiased account. Read about our editorial standards. Spotted an error? Let us know.