SBIR Phase I: Development of a Blood Test for the Detection of Transthyretin Amyloidosis

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of a simple blood test to enable earlier and more accurate diagnosis of a progressive and often overlooked cause of heart failure in older adults. This disease, caused by the buildup of misfolded proteins in the heart, affects an estimated 500,000 individuals in the United States, yet is rarely diagnosed in time for available treatments to be effective. Current diagnostic methods are costly, invasive, and frequently delayed by several years. The proposed blood test offers a low-cost, noninvasive solution that could reduce diagnostic costs by thousands of dollars per patient, facilitate timely treatment, and improve patient outcomes. In the long term, this project may also reduce the burden on the healthcare system by preventing unnecessary procedures and hospitalizations. Beyond its application to heart disease, the technology being developed may also lay the foundation for new diagnostics targeting other protein misfolding disorders such as Alzheimer’s and Parkinson’s disease, expanding both societal impact and commercial opportunity. This Small Business Innovation Research (SBIR) Phase I project seeks to create and validate a new laboratory test that detects harmful protein aggregates in blood samples. These misfolded proteins accumulate in the heart and are difficult to measure with current tools. This project is focused on transforming a newly discovered protein-binding molecule into a reliable, high-throughput test that can be run on standard laboratory equipment. The work includes designing the test format, evaluating multiple antibody and detector combinations, and performing validation experiments to ensure accuracy, reproducibility, and sensitivity. The project will also assess the test’s performance in a variety of patient samples to determine its real-world diagnostic potential. Successful completion of this project will result in a validated test that enables earlier diagnosis of a disease that is currently under-recognized and under-treated and will provide the technical foundation for regulatory engagement and commercial deployment. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.