FDA Panel Skips Deliberation, Just Lets the Test Diagnose Its Own Fate
Advisers reportedly figured if the machine can find fifty cancers, it can probably find a yes or no too.
Faced with hours of prepared testimony and slide decks, the advisory panel convened Tuesday and, after a brief huddle, decided the fastest path forward was to simply draw blood from each member and run it through the very machine they were supposed to be evaluating.
"We came together as one panel, undivided," said a spokesperson for the group, before excusing themselves to have their own sample re-run for a second opinion. "The test found several things. One of them was apparently our vote."
According to people familiar with the proceedings, the readout arrived not as a medical result but as a printed recommendation slip, which the panel chair read aloud to the room without further discussion. Committee staff have since been asked to determine whether procedural rules permit a blood test to serve as both subject and adjudicator of its own hearing.
Grail representatives, watching from the gallery, reportedly applauded the efficiency, noting that a test capable of screening for fifty forms of cancer should have no trouble screening for a single up-or-down vote. Panel members who asked to be excluded from the blood draw were told there was no abstention option built into the cartridge.
The hearing adjourned early, with staff scheduling a follow-up session to review whether the test's recommendation regarding its own approval should itself be reviewed by another sample of the same test.