Giner, Inc.

Field Instrument for Assessment of Arsenic Exposure - Project Summary Human Exposure to Toxic Heavy Metals Existing in Drinking Water, Food, and the Environment Is an Area of Increasing National and International Concern. Heavy Metals Are Significant Environmental Pollutants Because They Tend to Persist, Bioaccumulate and Can Result in Serious Adverse Acute or Chronic Health Effects After Ingested or Inhaled. Traditionally, Trace Metals Are Measured From Human Tissues or Fluids (blood or Urine) in Centralized Laboratories Using Complex Analytical Methods Such as High-performance Liquid Chromatography (HPLC) or Inductively Coupled Plasma Mass Spectroscopy (icp-ms). However, in View of the Intensive Labor, Analytical Costs and Long Turnaround Times Associated With Centralized Laboratory Analyses, There Is an Immediate Need for a Portable and Inexpensive System for On-site Monitoring of Human Exposure to Heavy Metals. These Rapid, Field Measurements of Human Exposure in the Population Would Greatly Help Epidemiology Researchers to Conduct Their Studies and Also Help the Regulatory Institutions With Better Determination of Safety Limits and Prevention of Diseases Caused by Heavy Metal Exposures. an Important Goal of This Direct to Phase Ii Proposal Is to Develop a Technology That Meet the Technical and Practical Needs of Environmental Researchers, Clinicians, and Epidemiologists. the Ultimate Goal Is to Deliver a Reliable Field Prototype of a Sensing Instrument for the Current Unmet Needs for Rapid Testing of Trace Amounts of Metals in Urine Samples, and to Accelerate the Commercialization of This Product. in This Phase Iib Study, Giner Will Develop and Demonstrate the Heavy Metals Monitor Prototype From Bench-top Assay Platform to a Field-ready Instrument With a Portable Size, With Integrated Components for Assay Operation, Electronic Units and Software Packages for Data Processing and User Interface. Meanwhile Giner Will Develop and Fabricate a Series of Disposable Microfluidic Lab-on-a-chip Cartridge for Convenient Measurements of Multiple Metal(s) and Metal Combinations From Large Numbers of Human Subjects. the Various Cartridge Designs Will Allow the Monitor Instrument to Determine the Presence and Concentrations of Multiple Metals. the Overall Performances of the Prototype Will Then Be Evaluated Thoroughly Through a Large Scale of Field Testing With Four Renowned Epidemiology Collaborators, as Well as a Team of User Experience Specialists, Which Would Improve the Sensing Capabilities, Tool Reliability and Usability Towards Commercialization. This Proposed Project Will Achieve a Critical Step Towards the Commercial Release of a Heavy Metal Field Monitor, Which Has the Potential to Become a Critical Tool to Support Environmental and Public Health Community for Developing Strategies to Prevent Toxic Metals-related Diseases. Giner Is Teaming Up With Leading Commercial Partners Which Specialize in the Development and Commercialization of Screening and Diagnostic Technologies.