Key Achievements

  1. Immobilization:
    Conducting polymer
    Micropatterned electrodes
    Electric-induced deposition
  2. Recognition:
    E-field acceleration
    Individually optimized parameters
    Increased efficient concentration
  3. Detection:
    Hairpin probe amplifys signal specifically
    Self-driven fluidics make system simpler
  4. Specifications:
    LOD 1 fM for RNA
    LOD 1 pg/mL for protein markers.
    Less than 20 mins for multiplexing detection
    About 90% accuracy oral cancer diagnostics

Point of Care Technology


About

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 NIDCR'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-Instrument) 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.