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FDA Panel Endorses Grail's Multicancer Test, Cautions on Data Gaps
Developing
In Short: An FDA advisory panel voted that Grail's Galleri multicancer detection test is safe and effective, with benefits outweighing risks, but highlighted significant data gaps.
The panel, however, noted a critical lack of evidence showing that the test reduces mortality.
Dr. Stanley Lipkowitz, an oncologist and committee member, emphasized the importance of mortality data, stating, 'As an oncologist, I generally look at that as outcomes, and we don’t have that data.
Panelists also called for more postmarketing data to determine if the test has any impact on mortality and to establish an appropriate testing interval.
In a series of votes, the panel agreed on the test's safety (10-0), effectiveness (6-4), and the balance of risks and benefits (7-2, with one abstention).
The committee did not explicitly vote on whether to approve the MCED test, but some panel members expressed concern that approval could lead to widespread testing outside of the indicated use, potentially lacking population-wide benefit.
What's still developing
- An FDA advisory panel said the benefits of Grail’s multicancer detection test outweigh its risks but acknowledged that there is no proof that the diagnostic can reduce mortality.
- In a series of votes, the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee agreed that Grail’s Galleri multicancer early detection (MCED) test was safe (10 yes, 0 no) and effective (6-4), and that the benefits outweighed the risks (7-2, with one abstention).