Mass spectrometry (MS) is the gold standard for chemical analysis and has been widely applied due to its high sensitivity, high specificity as well as high quantitation precision. Traditional chemical analysis using MS requires complex procedures, including multiple steps for sample preparation, chromatographic separation, MS analysis and data analysis. Equipment typically required is large and of high cost for ownership (~$400K) and maintenance. The entire procedure is labor intense and requires expertise in laboratory techniques for analytical chemistry and mass spectrometry. In this proposed project, PURSPEC Technologies Inc., in collaboration with Purdue University, will develop a new mass spectrometry product that will transform the MS analysis for point-of-care (POC) applications. PURSPEC Technologies, Inc., an Indiana-based small business, has been founded to develop miniature MS products based on the research development at Purdue University, which has been sponsored by NIH projects 1R01GM106016 and 1R21RR031246. A series of technologies and research prototypes have been developed at Purdue for ambient ionization and miniature of mass spectrometers. The proposed product will address the shortcomings of the existing MS products for laboratory and in-field applications and will fulfill an unmet need in the commercial market for drug discovery and clinical analysis. Due to the depth of existing knowledge and the expertise of the team involved, as well as successful preliminary and feasibility studies, PURSPEC is seeking a Direct to Phase II award. The goal of this STTR Direct to Phase II is to develop a complete POC-MS system as a product prototype and its associated operational protocol for chemical analysis at local clinical sites and ultimately for personal health care.
Aim 1 : Develop a product prototype for POC MS system with improved robustness, enhanced sensitivity and quantitation precisions;
Aim 2 : Design the sampling cartridge and optimize the sample handling protocol;
Aim 3 : Develop the software and database supporting the POC-MS system; and, Aim 4: Validate the integrated POC-MS system and analysis protocols. The expected outcome from the Phase II efforts is the delivery of the product prototype of a first POC-MS system with a relatively complete solution for clinical analysis. Immediately following the successfully Phase II, PURSPEC will prepare to commercialize the affordable, easy-to-use and self-contained portable device. A considerable market exists for such a device.
The proposed research will lead to the development of a first point-of-care mass spectrometry product for direct analysis of raw biological samples. It has strong relevance to general public health by providing a powerful tool for fast, easy, highly sensitive, selective and quantitative chemical monitoring for clinical diagnosis or personal health care.