Impact of VALID Act implementation on mass spectrometry-based clinical proteomic laboratory developed tests

IF 3.1 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY Journal of Mass Spectrometry and Advances in the Clinical Lab Pub Date : 2023-04-01 DOI:10.1016/j.jmsacl.2023.02.001

Yanchun Lin , Stefani N. Thomas

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Abstract

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.

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有效法案实施对基于质谱的临床蛋白质组学实验室开发的测试的影响

基于质谱（MS）的临床蛋白质组学实验室开发的用于测量与内分泌、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的测试（LDT）由于其在支持患者诊断和治疗决策方面的价值，在临床实验室中越来越受到重视。在目前的监管环境下，基于MS的临床蛋白质组学LDT由医疗补助和医疗保险服务中心（CMS）主持的临床实验室改进修正案（CLIA）进行监管。然而，如果《验证准确领先的体外临床试验开发法案》获得通过，它将授予美国食品药品监督管理局更大的权力来监督诊断试验，包括LDT。这可能会阻碍临床实验室开发新的基于MS的蛋白质组学LDT以支持现有和新出现的患者护理需求的能力。因此，本综述讨论了目前可用的基于MS的蛋白质组学LDT及其当前的监管格局，以应对《有效法案》的通过带来的潜在影响。

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