FDA advisers narrowly endorse multi-cancer blood test amid efficacy concerns
An FDA advisory committee voted 6-4 that the Galleri blood test, which detects DNA fragments from over 50 cancer types, is effective. The test, costing nearly $1,000, is intended for adults 50 and older but isn't meant to replace standard screenings. Doubts persist because a large NHS trial failed to reduce late-stage cancer diagnoses, though a separate study showed positive results.
The Galleri test analyzes DNA fragments to flag potential cancers across dozens of types. Its evidence is mixed: a large NHS trial of 140,000 people failed to reduce late-stage diagnoses, while a Grail-funded study of 32,000 adults found about 60% of positive results were true cancers, with most detected cases being early-stage and lacking routine screening.
The committee's 6-4 vote reflected this uncertainty, with some members calling their approval "hopeful" rather than definitive. The proposed label would state that a negative result doesn't rule out cancer and positive results need follow-up. The FDA's final decision, expected soon, will determine whether this nearly $1,000 test gains formal approval after being sold without it since 2021.
If approved, this test could reshape cancer screening for adults 50 and older, potentially catching malignancies that currently lack routine detection methods. However, its mixed trial results suggest it may not reliably reduce late-stage diagnoses or mortality, and false positives could trigger needless anxiety and procedures. Patients might gain earlier awareness, but could also face financial costs and false reassurance, influencing how healthcare providers and insurers approach multi-cancer screening.