Oral Fluid Diagnostics Research and Proposal

The McDevitt group is currently in the third year of a vital leadership role within a NIH/NIDCR funded U01 program specifically targeting the development and application of next-generation LOC systems for saliva-based cardiac diagnostics. Through this important program, the Texas Bio-nano-chip (NBC) sensor system has been adapted successfully to a number of important salivary diagnostic tests exhibiting the following characteristics:

• Multi-analyte detection capabilities
• Non-invasive oral diagnostic sampling
• Miniaturized formats
• Programmable assay designs
• Ultra-sensitive detection capacities
• Rapid assay periods (<20 minutes)

Low operating costs

Although the saliva research program has demonstrated capacity for a number of different diseases, our most important results are in the cardiac health arena. This funding program is making excellent progress in defining the relevant salivary biomarker targets and their time-course for AMI diagnosis, as well as in developing advanced micro-fluidic structures and the associated analyzer. Further work, seeks a better understanding of the contribution of oral disease to the measurements of salivary biomarkers of AMI. This same barrier exists for other systemic diseases that are to be measured with oral fluid tests and, as such, the information here gathered will serve to open the door for a series of other important salivary tests. This supplement program will benefit from the fore-mentioned advances and will also leverage clinical samples collected from orally healthy and periodontal disease patients, as well as of samples from an ongoing AMI ambulance study to accelerate progress in this important area. This high-profile program was recently selected as part of Science Coalition’s Best Scientific Advances for Year, as well as for the 2008 Popular Science’s “Best of What's New Award” in the Medical Device category for a new saliva heart attack test system and builds on the previous successes detailed below.

Important accomplishments:

• Achieved the lowest limit of detection to date for an important inflammation biomarker, CRP. Related News and Lab on a Chip Paper.
• Completed the initial measurements of the pathophysiological levels of CRP in oral fluids. Lab on a Chip Cover Article.
• Developed methods for multiplexed detection of inflammation markers - Analytical Chemistry Paper and Clinical Chemistry cardiac papers.
• Successfully correlated the microchip sensor technology with gold standard methods- Analytical Chemistry Paper and Clinical Chemistry papers.
• Rice University has made strong commitments to transition these academic findings into practical embodiments that can be used to help improve health care treatment through the development of the next generation of health care products - LabNow collaboration and broad collaboration team.
• Established multi-university, multi-center collaborations for clinical research and trials.