Grail cancer test nears FDA approval

Grail is nearing FDA approval for its Galleri cancer blood test following a positive advisory panel vote. However, widespread insurance coverage and Medicare reimbursement remain critical hurdles for commercial success.

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FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020.

GRAIL INC is advancing toward potential regulatory clearance in the United States following a favorable advisory panel vote last week. The milestone sets the stage for broader market adoption if federal regulators grant formal authorization. Widespread payer reimbursement remains the critical hurdle for commercial success.

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