2026年9月23日星期三,FDA顾问委员会以7比2(1人弃权)的投票结果,支持Grail公司的Galleri血液检测,该检测可筛查50岁及以上健康成年人体内超过50种癌症的信号。
FDA Advisory Panel Endorses Grail's Multi-Cancer Early Detection Blood Test On Wednesday, September 23, 2026, an FDA advisory panel voted 7-2 (with one abstention) to endorse Grail Inc.'s Galleri blood test, which screens for signals of over 50 types of cancer in healthy adults aged 50 and older.
虽然委员会认可该检测识别现有筛查手段无法覆盖癌症的潜力,但也警告称,该检测不能替代常规筛查,且缺乏降低癌症死亡率的证据。
While the panel acknowledged the test's potential to identify cancers without existing screenings, it warned that the test is not a replacement for routine screenings and lacks evidence of reducing cancer deaths.
FDA将在几个月内做出最终批准决定,这可能使该检测通过Medicare和私人保险覆盖而更广泛地普及。
The FDA will make a final decision on approval in a few months, which could lead to increased availability through Medicare and private insurance coverage.