SBIR-STTR Award

This Small Business Innovation Research Phase I project is to develop and commercialize a powerful new diagnostic assay platform for quantitative analysis of plasma from human blood using Differential Scanning Calorimetry. The platform will form the basis for generating novel high-throughput diagnostic assays requiring minimal sample handling and processing that can be performed in an hour on a single drop of blood. Output is in the form of a melting curve, or thermogram. Each thermogram provides a highly sensitive and specific signature for a variety of disease states including various cancers, auto-immune and infectious diseases. Thermograms establish a powerful new vista from which to view plasma diagnostics and provide an excellent complement to more traditional plasma diagnostic methods (electrophoresis and mass spectrometry) that separate plasma/serum proteins based on their mass and charge. The broader impacts of this research stem from the multiplicity of applications provided by the platform to be developed. These applications include: (1) Early stage disease detection, (2) Distinction between different stages of disease, remission and relapse (disease progression), (3) Assessing effects of therapeutic regimens and therapeutic monitoring, and (4) Identification of therapeutic targets for drug development (i.e. biomarker discovery). The universal platform provided by the plasma thermogram technology allows for the capability of detecting, diagnosing and monitoring a variety of very important diseases with high, unmet medical needs. This provides a multi-billion dollar opportunity for the commercialized plasma thermogram technology platform and diagnostic assays. This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5)

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