FDA staff have found no major concerns with the Galleri multicancer early detection (MCED) blood test, according to a review released ahead of an advisory committee meeting. The assessment covers the test's safety, accuracy, risks, and benefits, and found no major questions or issues.
The Galleri test is designed to detect multiple cancer types from a single blood sample. The FDA's advisory committee will convene Wednesday to discuss the test and make recommendations.
While FDA staff reviews are not binding, they often inform the committee's discussion and the agency's final decision. The source does not indicate any specific concerns raised by staff.