On September 23, the FDA’s Molecular and Clinical Genetics Panel reviewed GRAIL’s premarket approval application for the Galleri test. The panel voted 10 to 0 that there is reasonable assurance the test is safe, 6 to 4 that there is reasonable assurance it is effective, and 7 to 2, with one abstention, that its benefits outweigh its risks for the proposed indication (screening for early detection of multiple cancer types in adults 50 and older). The vote is advisory, and the FDA’s decision will come later. The vote counts are from the FDA’s 24-hour summary of the meeting, which also records the panel’s view that the test should not replace guideline-recommended screening and that the word “early” in the proposed intended use was not fully supported by the data.
I wrote an Expert Commentary for ASCO Daily News on what the vote changes for oncologists and on the three patient conversations to prepare for: (1) a “cancer signal detected” result, (2) a negative result, and (3) cost before the blood draw. It was published on September 30.
Read it here: Multicancer Early Detection Test Clears Its First FDA Hurdle
The day before the vote, the two studies at the center of the application were published as peer-reviewed papers: PATHFINDER 2 in Nature Medicine, and the NHS-Galleri primary results in the New England Journal of Medicine, with a companion paper on the test’s performance in NHS-Galleri in Nature Medicine. I have added a “Published” section to the PATHFINDER 2 and NHS-Galleri journal clubs on this site with the journal citations and the figures that changed.