W31P4Q13C0073

Small Business Innovation Research Program (SBIR) Phase II

Improved Dried Biological Specimen Materials, Recovery and Processing for Diagnostics

The dried blood spot (DBS) method is an alternative to venipuncture. The available data indicates that the DBS method is both precise and accurate for a diverse range of compounds. We discovered that proprietary additives vastly improve extraction of proteins in DBS using electrospray. Our unexpected results appear to dramatically increase analyte recovery concentration while reducing DBS prep, and may have a significant impact on ESI-MS methodology. We are proposing to apply and validate the extraction process over a comprehensive range of clinical panels, validate the test methods for clinical relevance with independent labs, investigate the role of our proprietary additives, and optimize the extraction method with several Universities. Our primary goal is to deliver a final system suitable for implementation into DARPA's ADEPT program. In a possible Phase II Option, we will continue development seeking FDA approval using a CLIA waived approach together with Yale New Haven Hospitals Clinical labs, which will assist in the clinical trials. The proposed program will have the following benefits: a dried analyte capture, storage, and recovery method that can be used by minimally trained individuals that yields CLIA waived clinically accepted tests for analyte panels now routinely reserved for whole blood or serum.

The goal of phase II is to continue the R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II.

SB112-005

D2-1159

2011.2

Mr. Joseph Bango