《有效法案》的实施对基于质谱的临床蛋白质组学实验室自建检测的影响
Impact of VALID Act implementation on mass spectrometry-based clinical proteomic laboratory developed tests.
作者信息
Lin Yanchun, Thomas Stefani N
机构信息
Department of Chemistry, Washington University in St. Louis, St. Louis, MO, USA.
Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN, USA.
出版信息
J Mass Spectrom Adv Clin Lab. 2023 Feb 13;28:30-34. doi: 10.1016/j.jmsacl.2023.02.001. eCollection 2023 Apr.
Mass spectrometry (MS)-based clinical proteomic Laboratory Developed Tests (LDTs) for the measurement of protein biomarkers related to endocrinology, cardiovascular disease, cancer, and Alzheimer's disease are gaining traction in clinical laboratories due to their value in supporting diagnostic and treatment decisions for patients. Under the current regulatory landscape, MS-based clinical proteomic LDTs are regulated by Clinical Laboratory Improvement Amendments (CLIA) under the auspices of the Centers for Medicaid and Medicare Services (CMS). However, should the Verifying Accurate Leading-Edge In Vitro Clinical Test Development (VALID) Act pass, it will grant the FDA greater authority to oversee diagnostic tests, including LDTs. This could impede clinical laboratories' ability to develop new MS-based proteomic LDTs to support existing and emerging patient care needs. Therefore, this review discusses the currently available MS-based proteomic LDTs and their current regulatory landscape in the context of the potential impacts imposed by the passage of the VALID Act.
基于质谱（MS）的临床蛋白质组学实验室自主研发检测方法（LDTs）用于测量与内分泌学、心血管疾病、癌症和阿尔茨海默病相关的蛋白质生物标志物，因其在支持患者诊断和治疗决策方面的价值，正在临床实验室中获得越来越多的应用。在当前的监管环境下，基于MS的临床蛋白质组学LDTs由医疗保险和医疗补助服务中心（CMS）主持下的临床实验室改进修正案（CLIA）进行监管。然而，如果《验证准确前沿体外临床试验开发（VALID）法案》获得通过，它将赋予美国食品药品监督管理局（FDA）更大的权力来监督诊断测试，包括LDTs。这可能会阻碍临床实验室开发新的基于MS的蛋白质组学LDTs以满足现有和新出现的患者护理需求的能力。因此，本综述在《VALID法案》通过可能产生潜在影响的背景下，讨论了目前可用的基于MS的蛋白质组学LDTs及其当前的监管环境。
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