Beacon Biotechnology's Point of Care Type I Diabetes Screen

* *除了简历外，申请中没有提供对团队的描述，因此很难评估质量。 3.创新： 优势 *开发廉价、简单、一次性、有吸引力的就诊筛查方法。 *抗原修饰的检测器是独一无二的。 *与附着在探测器表面的生物发光分子有关的固体IP。 弱点 *清楚说明为什么缺乏对糖尿病相关自身抗体检测的证明是不成功的。 *提案忽略了市场上的其他生物发光免疫分析产品。 *预计每台设备的成本是多少？仪器开发不是提案的一部分。 4.方法： 优势 *蛋白质制备的详细说明(例如，生物素化蛋白质的制备等)并使用比较两种方法对相关抗体进行定量的方法。 *为应对潜在的陷阱以及如果不符合敏感性或选择性标准(即相当于FDA批准的当前方法)而提出的替代方法。 弱点 *研究和设计只是比较了使用BrightSpot平台的两种技术。仪器设备既没有描述，也没有说明是否已经完成。 *初步数据主要基于混合血浆中艾滋病毒的应用情况。在使用血液的地方，它首先被稀释。这如何影响速度、检测极限和灵敏度尚不清楚。 *未涉及固定化抗原的稳定性/保质期问题。 5.环境： 优势 *公司似乎有足够的空间、设备和资源。 *团队还将利用科罗拉多大学丹佛分校的资源。 弱点 *无 对人类受试者的保护：不适用(无人类受试者) 脊椎动物： 不适用(无脊椎动物) 生物危害： 可接受 预算和支持期限： 建议的预算修改或确定的可能重叠： *没有实际证据表明需要额外6个月(总计12个月)的资金。 *预算对于拟议的工作来说太高了。从事与要求的建议书无关的工作的个人的工资(例如，FDA顾问、软件开发等)但这是没有根据的。 资源共享计划：不适用(无相关资源)

* * Description 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)