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Grail said on Friday the U.S. FDA plans to hold a meeting of outside experts to review its multi-cancer screening test Galleri in September, sending its shares up 5%.
The panel will review Grail's request for premarket approval, the Food and Drug Administration's most stringent review process for medical devices. The agency is not required to follow the panel's recommendation.
Grail 周五表示，美国 FDA 计划于 9 月召开外部专家会议，审查其多癌种筛查检测 Galleri，消息推动其股价上涨 5%。
该专家组将审查 Grail 的上市前批准申请——这是 FDA 对医疗器械最严格的审查流程。该机构不一定要遵循专家组的建议。
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