The primary objective of this SBIR Phase I project is the design, fabrication and validation of portable prototype instrumentation which will permit growers and other stakeholders in the agricultural community to rapidly and accurately diagnose plant infectious diseases, directly at the point of testing. Such infectious diseases, if incorrectly diagnosed and improperly treated, can result in devastating economic losses to the agricultural community and can adversely impact the safety of the nation's food supply. Growers presently rely on regional diagnostic laboratories (such as those of the U.S. National Plant Diagnostic Network) for diagnosis; this "central laboratory paradigm" adds logistical complexity and delays in disease diagnosis. In addition, this present model can also result in unexpected adverse outcomes -- for example, the inadvertent spread of highly infectious organisms during the transport of diseased plant samples from a distant location to a central laboratory. The Phase I effort represents an interdisciplinary collaboration between K2 BioMicro systems and researchers from the OSU Plant Clinic and Department of Botany and Plant Pathology at Oregon State University. The work will accomplish three major aims: the development of portable prototype instrumentation for plant sample preparation (a necessary step for subsequent testing); the design and fabrication of portable prototype instrumentation for DNA amplification (allowing for diagnosis of the underlying infectious cause of disease), and testing and validation of the prototype instruments. The final instrument validation step will involve close collaboration with OSU research staff, employing existing diagnostic assays presently used for testing of plant infectious diseases of importance to local growers. The instruments developed under Phase I will be portable, battery-powered and will enable rapid diagnosis directly at the point of testing, thus eliminating the cost, complexity, and delays associated with transporting plant samples to a remote central laboratory. Successful completion of the work will result in instrument prototypes for plant tissue sample preparation and DNA amplification (molecular diagnostics) which will serve as a foundation for subsequent work towards commercialization of the technology. These prototype designs will have broad applicability across many fields of biology and biomedicine, including infectious disease testing in human and veterinary medicine, food testing and security, pharmacogenomics (i.e., genetic testing for optimizing pharmacologic dosing in treatment of disease) and other specialty fields.
