Developing Technology to Remotely Measure Molecular Composition

There is a critical need for accurate and safe early stage detection of, e.g., infectious diseases, hazardous materials, and other

health related issues. Remote detection directly from surfaces, especially related to health concerns (in situ, in vivo) is an underserved area of immense utility. Thus, significant commercial opportunities exist because of the dearth of these

capabilities as “demonstrated” in the current double pandemics of Covid and drugs as well as persistent threats (bacterial,

fungi, cancers, bioagents, etc.). Mass spectrometry (MS), because of its ability to detect hundreds 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 or on surfaces or within compositions (e.g., drugs from Skittles), as examples. 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 direct sampling / ion source technology that provides for minimal user intervention and long-term

use without maintenance. These attributes are necessary if testing of hundreds of individual surfaces daily per instrument to

e.g., identify, track, and contain the spread of infectious agents, or to detect cancer in biopsied tissue or cancer boundaries during surgery 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 sampling device-transfer-ionization approach constitutes a disruptive technology and effective method

that can be used for the next-generation disease detection and health management. The basic invention of this project is covered by two MSTM provisional patent applications (April 3 and June 5, 2023), and earlier IP from inventors Trimpin (CEO of MSTM) and McEwen (President of MSTM) exclusively licensed from two universities to MSTM. In summary,

these developments and remote sampling research position MSTM well for advancing this exciting area in need of new technology. Critical advantages include exceptional ease and flexibility, on the fly results, remote sampling of 3- dimensional surfaces without and with the use of a laser, robustness to instrument contamination and carryover, and the

capability to retrofit with commercial atmospheric pressure ionization mass spectrometers to provide accurate, safe,

detection on demand. The objective of this Phase I project is to demonstrate the feasibility and proof-of-concept of the surface reader to sample surfaces directly with a liquid meniscus or indirectly by laser ablation. In Phase II, an FDA approved CO2 laser will be implemented along with machine learning algorithms in a commercial product requiring little

expertise to effectively operate. Aim 1: Build a proof-of-concept remote surface reader interfaced with an MSTM multiport inlet using SAI and VSAI MS for differentiation of diseased vs. normal tissue through computer aided m/z fingerprint

recognition. Aim 2: Test the remote transfer device of Aim 1 using real samples for demonstration and Phase II purposes.

MSTM has the necessary expertise and facilities to bring this Phase I project to a successful conclusion within 12 months. MSTM has enlisted help from knowledgeable companies (letters Advion, Bruker, Medtronic, Thermo, BioPharmaSpec).