Overview
- An FDA advisory committee voted Sept. 23 that the Galleri multicancer blood test is safe and that its benefits outweigh its risks, with a narrow split on effectiveness that will now go to the agency for a final decision.
- Galleri screens a single blood draw for cancer-linked DNA methylation patterns and can predict a likely anatomic origin when positive, but a positive result is not a diagnosis and requires imaging or biopsy to confirm.
- Pivotal trials showed very high specificity (about 99.7–99.85%) and positive predictive values of roughly 66–77% but modest 12‑month sensitivity of about 31–35%, meaning the test missed roughly two of every three cancers diagnosed within a year in study populations.
- Advisers and experts warned the test lacks evidence that it reduces deaths or late‑stage cancers, urged that Galleri be used in addition to guideline screenings rather than as a replacement, and recommended labeling that clearly explains limitations.
- If the FDA approves Galleri, insurers and Medicare could broaden access because a 2026 law directs Medicare to consider covering FDA‑approved blood‑based multicancer diagnostics starting in 2028, a change that could increase testing, follow‑up imaging, and clinical workload while postapproval studies collect longer‑term outcomes.