FDA Panel Endorses Grail's Galleri Blood Test Despite Efficacy Concerns

Key points

• FDA's Medical Devices Advisory Committee voted 10-0 on safety, 6-4 on efficacy, and 7-2 (with one abstention) that Galleri's benefits outweigh risks.
• Galleri, developed by Grail, detects DNA fragments in blood to screen for over 50 cancer types, including those without current screening options.
• The test costs nearly $1,000 and is currently sold without FDA approval; approval could enable coverage by private insurance and Medicaid.
• A major NHS trial involving 140,000 participants found no significant reduction in late-stage cancer diagnoses, raising efficacy questions.
• Panelists and experts warned that false negatives could create a false sense of security, and the test should not replace existing screenings.

Background

Grail's Galleri test has been available in the US since 2021 without FDA approval. Recent archive coverage highlights a large NHS trial that showed mixed results, detecting about 30% of cancers but failing to reduce late-stage diagnoses. Other studies, such as the UNC Vanguard Study, are evaluating multi-cancer blood tests, but none are yet approved for routine screening.

How outlets are covering it

STAT reported the panel's endorsement, emphasizing the vote that benefits outweigh risks. The Washington Post highlighted the controversy, noting the divided vote on efficacy and the NHS trial's failure to reduce late-stage diagnoses. The Associated Press (via cleveland19.com) focused on the test's limitations, such as missing two-thirds of cancers and the risk of false reassurance. Grail's CEO Josh Ofman praised the vote as reinforcing the test's clinical evidence, while critics like Dr. Emil Lou and Dr. Scott Ramsey warned about false positives and negatives. The FDA is not bound by the panel's advice but often follows it.

Why it matters

FDA approval for Galleri could revolutionize cancer screening by offering a single blood test for multiple cancers, potentially improving early detection for diseases currently lacking screening options. However, concerns about efficacy and false results remain significant.

What to watch

The FDA is expected to make a final decision on Galleri's approval in the coming months. If approved, the test could become covered by Medicare and private insurers, expanding access. Further studies are needed to confirm its long-term benefits and address efficacy concerns.