Development of multimode vacuum ionization for use in medical diagnostics

开发用于医疗诊断的多模式真空电离

• 批准号: 10697560
• 负责人: Charles N McEwen
• 金额: $ 15.91万
• 依托单位: MSTM, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-10 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10697560
• 关键词: 2019-nCoV; Achievement; American; Analytical Chemistry; Artificial Intelligence; Atmospheric Pressure; Automation; Automobile Driving; Award; Biochemistry; Biological; Body Fluids; COVID-19; Cessation of life; Chemicals; Chemistry; Collaborations; Communicable Diseases; Computer Assisted; Data; Detection; Development; Disease; Doctor of Philosophy; Equipment; Event; Exposure to; Faculty; Fingerprint; Future; Gases; Goals; Grant; Hand; Health; Health Technology; Healthcare; Healthcare Market; Individual; Industrialization; Industry; Infection; Infectious Agent; Intervention; Ions; Legal patent; Letters; Licensing; Maintenance; Manuals; Manufacturer; Mass Spectrum Analysis; Measurement; Mechanics; Medal; Medical emergency; Methods; Molecular; Overdose; Pain; Performance; Pharmaceutical Preparations; Phase; Play; Poison; Renaissance; Reproducibility; Research; Research Personnel; Safety; Saints; Sales; Sampling; Semiconductors; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Societies; Solid; Source; Spanish flu; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; Speed; Technology; Testing; Tissue Sample; United States National Institutes of Health; Universities; Urine; Vacuum; Virus; Volatilization; Water; Work; biothreat; clinical diagnostics; commercialization; cost; cost effective; current pandemic; design; design and construction; experience; fungus; high throughput technology; improved; innovation; instrument; instrumentation; interest; invention; ion source; ionization; ionization technique; machine learning algorithm; manufacture; mass spectrometer; member; new product development; new technology; next generation; operation; pathogen; portability; professor; programs; prototype; rapid testing; success; user-friendly

There is a critical need for rapid and cost-effective means for the detection of e.g. infectious diseases at an early stage, drug overdoses, and other health related testing necessities. Thus, significant commercial opportunities exist because of the lack of these capabilities as painfully “demonstrated” in the current pandemic. Mass spectrometry (MS), because of its ability to detect hundreds, even thousands, of biological compounds in a single acquisition provides the capability to distinguish chemical differences associated with, e.g., different pathogens and disease states, as well as target specific compounds in bodily fluids. Current MS approaches use ionization methods requiring user expertise and frequently specialized instrumentation, which significantly increases cost. Over the past 30 years, mass spectrometers have undergone a renaissance in their cost-to-capability ratio. For more widespread applications of MS in advancing healthcare, there is a need for new advanced ion source technology that provides for minimal user intervention and long-term use without maintenance. These attributes are necessary if testing of thousands of individuals daily per instrument to e.g., identify, track, and contain the spread of infectious diseases is to be implemented using MS in the future. The goal of this NIH SBIR Phase I project is to demonstrate that an entirely new ion source concept constitutes a disruptive technology and effective method that can be used for the next-generation disease test measurements. The basic invention of this proposal is covered by a MSTM patent application (#20210343518, March 31, 2021), and earlier IP exclusively licensed to MSTM which can be applied to widely available atmospheric pressure ionization mass spectrometers, including portable and ultra-high performance. Critical advantages include exceptional ease of use, robustness to instrument contamination and carryover, high-throughput, low cost, and the capability to retrofit with most commercial mass spectrometers to provide rapid, sensitive, and accurate data on demand. The objective of this Phase I project is to demonstrate the feasibility of this technology by constructing a manual dual vacuum ionization source that can be automated in Phase II for nearly hands-free operation and disease identification through machine learning algorithms. The specific aims towards establishing a potentially disruptive healthcare technology: Aim 1: Construct a manual vMAI/MALDI source capable of future automation (minimal viable product). Aim 2: Demonstrate high sensitivity, reproducibility, robustness, speed of analysis, as well as ease of use, quantification, accurate mass, MS/MS, and fingerprint analyses of pathogens. MSTM has the necessary expertise and facilities to bring this Phase I project to a successful conclusion within 9 months. Our strategy is to collaborate with one or more equipment manufacturer which is necessary to effectively expand into the healthcare market (letters Bruker, Medtronic, Thermo, Waters).

迫切需要快速且具有成本效益的手段来早期检测传染病、药物等。 因此，由于缺乏药物过量和其他与健康相关的检测必需品，因此存在巨大的商业机会。 这些能力在当前的大流行中被痛苦地“证明”了，因为它能够 在一次采集中检测数百甚至数千种生物化合物提供了区分的能力 与不同病原体和疾病状态相关的化学差异，以及目标特定化合物 当前的 MS 方法使用需要用户专业知识且经常专业化的电离方法。 仪器的成本显着增加，在过去的 30 年里，质谱仪经历了巨大的变化。 为了使 MS 在推进医疗保健方面得到更广泛的应用，其成本与能力比率得到了复兴。 需要新的先进离子源技术，以最少的用户干预和长期使用而无需 如果每天对每台仪器进行数千人的测试，例如识别、跟踪、维护，这些属性是必要的。 NIH SBIR 阶段的目标是在未来使用 MS 来实现。 我的项目是要证明一种全新的离子源概念构成了一种颠覆性的技术和有效的方法 可用于下一代疾病测试测量。 MSTM 专利申请（#20210343518，2021 年 3 月 31 日），以及早期 IP 独家授权给 MSTM，可 适用于广泛使用的大气压电离质谱仪，包括便携式和超高 性能的关键优势包括卓越的易用性、对仪器污染和残留的稳健性、 高通量、低成本，并且能够改装大多数商用质谱仪，以提供快速、 第一阶段项目的目标是证明这一方案的可行性。 技术通过构建手动双真空电离源，可以在第二阶段实现自动化，几乎免提 通过机器学习算法进行操作和疾病识别。 潜在颠覆性医疗保健技术：目标 1：构建能够实现未来自动化的手动 vMAI/MALDI 源 （最小可行产品）：展示高灵敏度、重现性、稳健性、分析速度以及 MSTM 具有病原体的易用性、定量、精确质量、MS/MS 和指纹分析的必要性。 凭借专业知识和设施，我们的策略是合作，以在 9 个月内成功完成第一阶段项目。 与一个或多个设备制造商合作，这是有效扩展到医疗保健市场所必需的（信件 布鲁克、美敦力、Thermo、沃特世）。