FDA 批准了 Exact Sciences 的 Cologuard Plus，这是一种用于结直肠癌筛查的下一代粪便 DNA 测试。 FDA approves Exact Sciences' Cologuard Plus, a next-gen stool DNA test for colorectal cancer screening.
美国食品和药物管理局批准了Exact Sciences的Cologuard Plus,这是一个新一代的便DNA测试,用于对45岁及以上的平均风险成年人进行结直肠癌查. The FDA has approved Exact Sciences' Cologuard Plus, a next-generation stool DNA test for colorectal cancer screening in adults aged 45 and older at average risk. 根据BLUE-C的研究,测试显示,癌症的敏感度为95%,先发性损伤的敏感度为43%,具体度为94%。 Based on the BLUE-C study, the test shows 95% sensitivity for cancer and 43% for advanced precancerous lesions, with 94% specificity. 计划于2025年发射,目的是减少假阳性,预计将列入《医疗保健计划》。 Planned for launch in 2025, it aims to reduce false positives and is expected to be covered by Medicare.