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FDA documents suggest favorable view for Grail cancer test before Wednesday meeting

The Food and Drug Administration posted documents suggesting a positive outlook for Grail's Galleri blood test ahead of an advisory committee meeting scheduled for Wednesday.

STAT+: What a vote on Grail’s cancer detection test could mean for the company, patients, and regulators
File photo STAT+: What a vote on Grail’s cancer detection test could mean for the company, patients, and regulators Photo: STAT

Stock prices rise on news

Shares in Grail jumped 33 percent on Monday following the release of the documents. Investors had been buying stock before the meeting to anticipate a good outcome. The company develops a blood test designed to find many cancers early.

Regulatory approval could help payers

FDA approval would likely lead to reimbursement from Medicare and other insurance companies. The test is already available as a laboratory-based diagnostic tool for patients. Experts will discuss the test at the upcoming advisory committee gathering.

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