Coverage for costs associated with reading of amyloid PET images from PARIS study

帕萨特奖项目总结 长期以来，人类阿尔茨海默病（AD）的研究一直受到以下事实的阻碍： AD诊断只能通过尸检后的脑病理学评估来确定。最近， 可直接对AD的两个标志（淀粉样斑块）进行成像的成像剂已经变得可用 和tau缠结）。然而，这些成像剂对于用于治疗是昂贵的和侵入性的。 例行诊断对低成本的基于血液的诊断测定的需求从未如此之大。C2n 诊断学一直在开发基于质谱的检测方法，以研究淀粉样β肽， 自2007年以来，生物β淀粉样蛋白的样品净化、纯化和质谱分析的最新进展 仪器使得可靠地定量人血浆样品中的β淀粉样蛋白成为可能。 来自华盛顿大学兰德尔·贝特曼博士实验室的初步数据显示， 血浆中的两种淀粉样β肽可以预测脑中淀粉样斑块的存在。这 技术可以彻底改变AD诊断领域，当出现在阿尔茨海默氏症 在2017年7月的国际会议上，这一发现被宣布为“迄今为止最大的新闻”。 AD临床研究的主要意见领袖之一。这一快速SBIR的具体目标- 跟踪应用程序是分析和临床验证C2 N的血浆检测，用作诊断测试， 预测大脑淀粉样变性

PROJECT SUMMARY FOR PARENT AWARD For a long time, the study of Alzheimer’s disease (AD) in humans has been hampered by the fact that absolute AD diagnosis could only be ascertained by assessment of brain pathology upon autopsy. More recently, imaging agents have become available that allow direct imaging of the two hallmarks of AD (amyloid plaques and tau tangles) in living humans. However, these imaging agents are expensive and invasive for use in routine diagnostics. The need for low-cost blood based diagnostic assays has never been greater. C2N Diagnostics has been developing mass spectrometry-based assays that investigate amyloid beta peptides in biofluids since 2007. Recent advances in sample cleanup, purification of amyloid beta, and mass spectrometry instrumentation have made it possible to reliably quantify amyloid beta in human plasma samples. Preliminary data from Dr. Randall Bateman’s laboratory at Washington University shows that the ratio of two amyloid beta peptides in plasma can predict the presence of amyloid plaques in the brain. This technology could revolutionize the field of AD diagnostics, and when presented at the Alzheimer’s Association International Conference in July 2017, this discovery was pronounced as “by far the biggest news of the meeting” by one of the key opinion leaders in AD clinical research. The specific aims of this SBIR Fast- Track application are to analytically and clinically validate C2N’s plasma assay for use as a diagnostic test for predicting brain amyloidosis.