Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California 90048, USA.
Mol Diagn Ther. 2010 Feb 1;14(1):13-22. doi: 10.1007/BF03256349.
The search for an effective screening test for the early detection of ovarian cancer has been intensive. Transvaginal ultrasound and the serum biomarker cancer antigen 125 (CA125) have been used clinically for decades in high-risk populations despite the lack of evidence demonstrating efficacy. More recently, new technologies have identified novel biomarker panels that attempt to improve on the performance of currently available modalities. Some of these tests report superior performance characteristics (sensitivity, specificity, positive predictive value) when compared with CA125 testing alone. Based on early encouraging studies, two commercial ovarian cancer screening products were recently marketed to the public and medical community. They were both withdrawn after concerns were raised by the US FDA and the scientific community regarding their validation and efficacy. There is no clear and established pipeline for the development and approval of these types of tests, and the FDA is working to fill in a large regulatory gap. In order to minimize the potential for public harm, an ovarian cancer screening test will need to be appropriately tested before being made available to the general population. In this review, we discuss the current state of biomarker development for the early detection of ovarian cancer and explore the continuing challenges to realizing this goal.
寻找一种有效的筛查试验来早期发现卵巢癌一直是研究的热点。尽管缺乏证明其有效性的证据，但经阴道超声和血清生物标志物癌抗原 125（CA125）在高危人群中已经临床应用了几十年。最近，新技术已经确定了新的生物标志物组合，试图改善现有模式的性能。与单独使用 CA125 检测相比，其中一些检测报告具有更好的性能特征（敏感性、特异性、阳性预测值）。基于早期令人鼓舞的研究，最近有两种商业卵巢癌筛查产品推向公众和医学界。但由于美国 FDA 和科学界对其验证和疗效提出了担忧，这两种产品都被撤回。这些类型的检测的开发和批准没有明确和既定的流程，FDA 正在努力填补这一巨大的监管空白。为了最大程度地减少公众受到伤害的风险，在向普通人群提供卵巢癌筛查试验之前，需要对其进行适当的测试。在这篇综述中，我们讨论了早期发现卵巢癌的生物标志物开发的现状，并探讨了实现这一目标所面临的持续挑战。
