Will FDA advisers recommend a multi-cancer blood test for approval? They'll vote

A key advisory committee that reviews medical devices for the Food and Drug Administration will meet today to vote on whether the agency should approve the first multi-cancer blood test. Grail, the company that makes the Galleri blood test under review, says it can detect up to 50 forms of cancer, many of which are not routinely screened for today.

The panel of independent experts will hear from Grail, FDA officials and the public before voting on a recommendation. The FDA often follows the advice from its panels, but does not have to. Ultimate approval by the agency could mean insurance reimbursement for the test, which costs $949.

There are hundreds of companies chasing the promise of blood tests to detect cancer, which is done with a simple blood draw and could help detect disease earlier by looking for genetic material or other cancer markers shed in blood or saliva. Grail says its Galleri test should be additive to standardized cancer screenings, like colonoscopies and mammograms, and not be used as a replacement.

While blood tests for cancer already exist in the market, none that screen for multiple cancers has undergone safety and accuracy reviews to win FDA approval so far. Many doctors and patients hope such technology will ultimately help detect disease earlier, when more treatment options could be possible.

The financial incentives to win FDA approval also became far more powerful, after Congress approved Medicare to cover multi-cancer detection tests that are greenlighted by the agency. Based on its promise, the FDA expedited its review of Galleri, which is the furthest along in that approval process.

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As such, Galleri is seen as a kind of bellwether for the whole industry – and for the potential use of a blood test to screen for cancers in general.

"It's a new era for early cancer detection, and if the FDA approves it, it validates the overall concept," says Cristian Tomasetti , director of City of Hope cancer center's early detection and monitoring division. In 2018, Tomasetti was part of a team that developed a competing blood test technology that is the basis of a test made by Exact Sciences (since purchased by Abbott), which is also pursuing FDA approval. (Tomasetti is no longer involved with that company.)