An FDA advisory committee is set to vote Tuesday on whether to recommend approval of the Galleri multi-cancer blood test. Grail, the developer behind the test, states it can identify up to 50 forms of cancer, including many types that lack routine screening protocols.
The independent panel of experts will hear testimony from Grail representatives, FDA officials, and members of the public before casting their vote. While the agency typically follows its advisory panels’ recommendations, it is not obligated to do so. Final approval could pave the way for insurance reimbursement for the test, which carries a price tag of $949.
Though cancer-detecting blood tests are already available, none designed to screen for multiple cancer types simultaneously has successfully completed the safety and accuracy reviews required for FDA clearance. The legislation passed by Congress this year, authorizing Medicare coverage for such tests, has significantly increased the financial stakes for developers like Grail.
Galleri is currently the most advanced candidate in the approval process. The FDA expedited its review based on the test’s potential, making it a bellwether for the broader industry and the future of early cancer detection via blood work.
“It’s a new era for early cancer detection, and if the FDA approves it, it validates the overall concept,” said Cristian Tomasetti, director of the early detection and monitoring division at City of Hope. Tomasetti previously helped develop competing technology now used in a test by Exact Sciences, which is also seeking FDA approval.
The advisory committee will evaluate two major clinical studies: one involving more than 140,000 patients in the UK’s National Health Service and another with over 35,000 North American participants aged 50 and older. Both studies have generated some controversy regarding their interpretation.
While the Galleri test did not meet its primary endpoint of reducing overall mortality or the combined incidence of Stage III and IV cancers, Grail has provided subsequent clarifications regarding Stage IV diagnoses in the NHS study. The FDA has asked the committee to determine whether the clinical data supports marketing claims about the test’s ability to detect cancer reliably and early.
Regulators are also focused on the potential harms associated with false results. The committee may require Grail to include specific caveats in its marketing materials, such as warnings that a negative result does not definitively rule out cancer, nor does a positive result confirm its presence.
Finally, a test that doesn’t just look at one organ. The future of screening is blood work, not scopes.
This could change everything for cancers like pancreatic ones that usually go undetected until it’s too late.
False positives are a huge worry. What happens if someone gets a false alarm and undergoes invasive surgery?
Will Medicare actually cover this now? That legislation seems crucial for average families to afford it.
I’m skeptical about the mortality data. Did they really show it saves lives, or just find more Stage IV cases?
$949 is steep, but imagine catching cancer early enough to actually cure it. Worth the cost for me.