Biomatrica, Inc. — Department of Defense SBIR Phase II: A11-107

Description

The projects objective is the development of a scalable all ambient temperature biological sample workflow preserving the nucleic acids for molecular analysis. This ambient workflow can be developed for large scale blood collection, transport and long-term archiving without the use of costly and unreliable cold-chain management, using commercially available biopreservation products. Since the completion of the human genome project in 2001, nucleic acid (DNA and RNA) based analysis has proven to be the most powerful diagnostic tool currently available to create actionable prediction of human health and understand and prevent disease development. The complexity of the human genome requires large sample populations to increase the predictive value of genetic analysis. Large scale archiving of population and/or patient specimens is the key to create this knowledge base. The pioneering work of Biomatrica over the past decade in the field of chemical biomaterial preservation at room temperature has allowed low cost alternatives to unreliable cold chain management. In Phase I we successfully demonstrated the power of chemical ambient preservation of nucleic acids throughout the workflow from blood sample collection and transport to the reliable storage of nucleic acids. We demonstrated that a) diagnostic analysis can be performed after storage in the ambient biopreservation products, b) the integrity of the DNA and RNA are pristinely maintained using ambient preservation c) the workflow is scalable from collection to archiving at lower costs and higher reliability than the current cold chain-based workflow. The Phase II development will result in the integration of proven commercial products into a highly scalable process, with the integration of automation equipment, the establishment of Standard Operating Procedure (SOPs) and an optimized workflow that reduces operational costs. The automated methods can be directly implemented for blood sample processing and archiving of nucleic acids in a routine setting.