The objective for this Phase II application is to develop a cartridge-based automated molecular diagnostic platform to rapidly and cost-effectively detect and identify influenza viruses. The system will automate all key functions for sample processing including extraction, amplification, colorimetric detection on a low- density microarray, and image/result interpretation. The idea is to make the system easy to use so that personnel with no PCR or microarray experience could obtain an unequivocal answer with minimal hands- on time. The motivation for the proposed work is the tremendous impact influenza viruses have on human and animal health and the need for rapid, inexpensive tools for strain surveillance. The intent is to significantly enhance influenza virus surveillance by providing a new tool to affordably and rapidly identify influenza viruses without expertise in PCR methods and without exclusive reliance on existing, sometimes poor performing, rapid immunoassays. The marketing plan involves providing the instrument to customers at no capital cost (i.e., the "reagent rental" concept). Therefore, the instrument will be designed with simplicity and low cost in mind. Our market entry point will be influenza surveillance sites, such as state public health labs, where the FluChip assay could be used to track viruses without the need to diagnose patients. Long term, we will use data acquired in these early studies to formulate an FDA submission for 510(k) clearance for use as an in vitro diagnostic.
The objective of the proposed work is to build on the success achieved in Phase I for rapidly identifying influenza viruses by developing a cartridge based system for automated and self-contained sample processing, including extraction, amplification, and colorimetric detection on a low-density microarray.