There are pervasive storage and transport problems that currently limit the accuracy of diagnostic tests and distribution of robust testing devices for remote usage. These problems stem from the inherent temperature stabilities of the molecules and reagents required for sensitive quantitation including antibodies, enzymes, protein standards, and the test specimens themselves (i.e. whole blood, saliva, urine, etc.). This I-Corps team proposes a technology platform based on using silk fibroin as a stabilizer that can be used to protect these molecules from degradation at ambient temperatures, which in turn can expand the use cases of diagnostic devices deployed in the field, will reduce the costs associated with cold storage, improve the shelf life of precious internal standards or immobilized chemistries on sensors, and potentially make the retrieval of fluid bio-specimens more feasible.
The silk technology platform offers many potential avenues for commercial development within the field of diagnostics. The initial work conducted by this team has focused on adapting silk purification and formatting to improve its stabilizing features (i.e. thermal protection / improved recovery) for needs in field settings. The team has also recently demonstrated thermal stability enhancements provided by the silk matrix across a wide number of test markers and demonstrated compatibility with numerous distinct testing techniques such as immunoassays, quantitative real-time PCR, and various high-throughput approaches. The team proposes the reduction of these core concepts to the retrofitting of existing products with poor thermal stability and the development of new products enabled by the technology, including point-of-care devices and sample vials containing labile reagents. I-Corps funds will support the development of a prototype device that incorporates a dried silk matrix and can be used to capture and dry capillary blood on an ergonomic and inexpensive consumable.
