Development of multimode vacuum ionization for use in medical diagnostics

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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).