of team not provided in the application aside from CVs thus making it difficult to assess quality. 3. Innovation: Strengths * Development of inexpensive, simple, disposable, point-of-care screening method attractive. * Antigen-modified detector is unique. * Solid IP concerning bioluminescent molecules attached to the surface of a detector. Weaknesses * Clear description why ELISA has not proven successful for diabetes-related autoantibody testing lacking. * Proposal ignores other bioluminescence immunoassay products on the market. * What is envisioned cost per device? Instrument development not a part of the proposal. 4. Approach: Strengths * Detailed description of protein preparation (e.g., preparation of biotinylated proteins, etc.) and use methodology comparing two methods for quantifying the relevant antibodies. * Alternative approaches proposed to counter potential pitfalls and if sensitivity or selectivity criteria are not met (i.e., equivalent to current FDA approved methods). Weaknesses * Research and design merely compares two techniques that employ the BrightSPOT platform. Instrumentation neither described nor made clear if already complete. * Preliminary data based predominately on HIV application in pooled plasma. Where blood is used, it is first diluted. How this influences speed, limit of detection and sensitivity not clear. * Stability/shelf-life of immobilized antigen not addressed. 5. Environment: Strengths * Company seems to have adequate space, equipment, and resources. * Team will also take advantage of resources at the University of Colorado-Denver. Weaknesses * None Protections for Human Subjects: Not Applicable (No Human Subjects) Vertebrate Animals: Not Applicable (No Vertebrate Animals) Biohazards: Acceptable Budget and Period of Support: Recommended budget modifications or possible overlap identified: * No real evidence of need for additional 6 months (12 totals) of funding. * Budget too high for proposed work. Salary for individuals conducting work unrelated to proposal requested (e.g., FDA consultant, software development, etc.) but not warranted. Resource Sharing Plans: Not Applicable (No Relevant Resources)
Type 1 diabetes strikes most often during childhood and invariably lasts for the rest of one's life. Preventing the disease is a key goal but requires learning how to identify people at high risk for developing the disease. Beacon Biotechnology's Point Of Care Type I Diabetes Screen is a rapid test designed to detect anti-islet antibodies, which nearly always precede the onset of diabetes, helping clinicians to identify high-risk individuals.
