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.
