This Small Business Innovation Research (SBIR) Phase II project will develop a powerful new diagnostic assay platform that will form the basis of a novel high-throughput diagnostic assay for detection and differential diagnosis of six autoimmune diseases: Lupus, Rheumatoid Arthritis, Multiple Sclerosis, Scleroderma, Polymyositis, and Lyme disease. Assay output is a differential scanning calorimetry (DSC) thermogram that is a characteristic signature for an individual's plasma or serum. The characteristic pattern provides a quantitative measure of the manifold components comprising an individual's plasma/serum, thereby providing an entirely new metric with which to analyze the fluids. The goal is completion of the necessary R&D objectives required to build a prototype diagnostic assay based on the plasma thermogram technology platform. Activities and experiments are directed at automating and optimizing laboratory assay capabilities; defining essential assay parameters and quantitative metrics; and testing and validating the prototype assay.
The broader impact/commercial potential of this project is the radical alteration of treatment paradigms, improved patient outcomes and reduced costs of patient care for complex diseases like autoimmune diseases. As many as 24 million people in the USA are affected by autoimmune disease. Convenient, quantitative and cost-effective diagnoses for numerous diseases, including targeted autoimmune diseases are not readily available. Early differential diagnosis between these diseases is an important unmet medical need and critical for timely and accurate treatment of disease and its complications. In addition, early accurate diagnosis potentially mitigates the costs and inconvenience associated with redundant administration of the current immunological, serological, clinical and pathological tests. Thus, a non-invasive blood assay like the plasma thermogram test that can differentially diagnose autoimmune diseases will be highly beneficial. The company will establish a CLIA (Clinical Laboratories Improvement Act) laboratory from which to market and sell the plasma thermogram test. A central laboratory offers a fast, low cost and high revenue business model for introducing new diagnostic tests into the marketplace. Commercialization of the thermogram technology platform represents a potential multi-million dollar market opportunity.
This project developed a powerful new diagnostic assay platform to form the basis of a novel high-throughput diagnostic assay for disease detection and diagnosis. Assay output is a thermogram that is a characteristic signature for an individual's plasma or serum. The characteristic pattern provides a quantitative measure of the manifold components comprising an individual's plasma/serum; and thereby provides an entirely new metric with which to analyze plasma/serum. Thermograms also provide an excellent alternative or complement to more traditional methods (electrophoresis and mass spectrometry) that separate plasma/serum proteins based on their mass and charge. A prototype diagnostic assay and clinical instrument based on the plasma thermogram technology platform was developed during the project. Assay automation and laboratory assay capabilities were also optimized and served to further define essential assay parameters and quantitative metrics. A prototype diagnostic assay was tested and validated that served to demonstrate utility of the diagnostic assay platform. Our use of the thermogram technology platform for disease diagnosis represents one of a multiplicity of applications for the diagnosis and monitoring of important diseases with high, unmet medical needs. Commercialization of the thermogram technology platform provides a multi-billion dollar market opportunity. Pathologists and other key medical providers that might benefit from plasma thermogram analysis for diagnosis and treatment decisions serve as initially targeted customers for our reference laboratory and testing service.
