[纸牌屋?] 这是一座纸牌屋
1Biologiste, généticien, Président d'Aprogène (association pour la promotion de la génomique), Marseille, France.
概括
多种癌症早期检测测试正在获得引力,但面临不完全的临床验证. 尽管缺乏FDA的批准和补偿,但销售额很高,主要是市场作而不是经过证明的疗效.
科学领域:
- 生物技术是生物技术.
- 医学诊断 医学诊断 医学诊断
- 在瘤学瘤学.
背景情况:
- 多种癌症早期检测 (MCED) 测试正在产生显著的商业兴趣.
- 尽管热情和销量很高,但许多MCED测试缺乏FDA的批准和补偿.
- 对MCED测试的临床验证仍在进行中,并且尚未完成.
研究的目的:
- 批判性地评估多种癌症早期检测测试的现状.
- 检查市场热情和临床验证状态之间的差异.
- 解决生物技术领域关于MCED测试的不合理作现象.
主要方法:
- 审查关于MCED测试开发和验证的当前文献.
- 分析市场趋势,销售数据和领先的MCED测试的监管地位.
- 商业可用性与临床证据的比较评估.
主要成果:
- 对于未经FDA批准或退款的MCED测试,销售量很大.
- 许多MCED测试的临床验证数据仍然不足以支持广泛采用.
- 生物技术市场表现出一个强有力的科学证据之前的作模式.
结论:
- 目前,MCED测试的商业成功超过了其临床验证.
- 迫切需要严格的临床证据来证明市场的热情和销售.
- 建议对目前围绕未经证实的MCED技术的作保持谨慎.
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