The ability to detect and monitor disease states through totally non-invasive means has been an elusive goal for the diagnostic industry. While oral fluid (saliva) is readily available and completely non-invasive, its utility in clinical diagnostics has only recently been demonstrated. Our team at UCLA, and others, has shown that oral fluid harbors the same composition of disease biomarkers as serum, albeit in smaller quantities. The team has also demonstrated, as part of NlDCR's """"""""Development of Technologies for Saliva/Oral Fluid Based Diagnostics"""""""" program, a microfluidic-based micro/nano sensor (Oral Fluid MEMS/NEMS Chip [OFMNC]) for the ultrasensitive, ultraspecific detection of oral cancer biomarkers in saliva. This application includes three highly responsive Specific Aims.
Aim 1 will develop the """"""""Oral Fluid NanoSensor Test (OFNASET)"""""""" as a handheld and easy to use instrument (OFNASE-lNSTRUMENT) and associated microfluidic consumables (OFNASE-CARTRIDGE). This integrated system will enable the simultaneous and rapid detection of multiple salivary protein and nucleic acid targets.
Aim 2 will analytically validate the OFNASET according to diagnostic-industry standards.
Aim 3 will preliminarily demonstrate the clinical utility of OFNASET for clinical oral cancer screening. The proposed work will culminate with the design of a pre-market approval (PMA) clinical trial to be presented to the FDA in a pre-IDE meeting. Our vision is to improve patient care by speeding the commercialization of saliva-based diagnostics. We believe that our established strategic alliances with GeneFluidics (a leader in bionanotechnology and microfluidics) and Becton Dickinson (the world's fifth largest clinical diagnostic company) will bridge the chasm between technology conceptualization and commercialization and make our vision a reality. For public: This proposal is to achieve the goal of develop, validate and achieve regulatory FDA approval of tools that can be used by dentists and doctors for in-office real time detection of oral cancer using a drop of saliva. ? ? ?

National Institute of Health (NIH)
National Institute of Dental & Craniofacial Research (NIDCR)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Special Emphasis Panel (ZDE1-GH (49))
Program Officer
Shum, Lillian
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of California Los Angeles
Schools of Dentistry
Los Angeles
United States
Zip Code
Lin, Chien-Chung; Huang, Wei-Lun; Wei, Fang et al. (2015) Emerging platforms using liquid biopsy to detect EGFR mutations in lung cancer. Expert Rev Mol Diagn 15:1427-40
Yang, Jieping; Wei, Fang; Schafer, Christopher et al. (2014) Detection of tumor cell-specific mRNA and protein in exosome-like microvesicles from blood and saliva. PLoS One 9:e110641
Ai, Ji-Ye; Smith, Barry; Wong, David T W (2012) Bioinformatics advances in saliva diagnostics. Int J Oral Sci 4:85-7
Spielmann, N; Wong, D T (2011) Saliva: diagnostics and therapeutic perspectives. Oral Dis 17:345-54
Li, Na (2010) Detection of Non-Nucleic Acid Targets with an Unmodified Aptamer and a Fluorogenic Competitor. JALA Charlottesv Va 15:189-197
Henson, Bradley Stephen; Wong, David T (2010) Collection, storage, and processing of saliva samples for downstream molecular applications. Methods Mol Biol 666:21-30
Lillehoj, Peter B; Wei, Fang; Ho, Chih-Ming (2010) A self-pumping lab-on-a-chip for rapid detection of botulinum toxin. Lab Chip 10:2265-70
Wei, Fang; Lillehoj, Peter B; Ho, Chih-Ming (2010) DNA diagnostics: nanotechnology-enhanced electrochemical detection of nucleic acids. Pediatr Res 67:458-68
Ai, Jiye; Smith, Barry; Wong, David T (2010) Saliva Ontology: an ontology-based framework for a Salivaomics Knowledge Base. BMC Bioinformatics 11:302
Giannobile, William V; Beikler, Thomas; Kinney, Janet S et al. (2009) Saliva as a diagnostic tool for periodontal disease: current state and future directions. Periodontol 2000 50:52-64

Showing the most recent 10 out of 24 publications