Serum biomarker discovery in early onset type 2 diabetes

早发 2 型糖尿病血清生物标志物的发现

• 批准号: 6990951
• 负责人: CHRISTINE CHAVANY
• 金额: $ 14.35万
• 依托单位: MILAGEN, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-15 至 2006-03-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6990951
• 关键词: antibody; biomarker; biotechnology; blood proteins; diagnosis design /evaluation; early diagnosis; human tissue; immunologic assay /test; metabolism disorder diagnosis; noninsulin dependent diabetes mellitus; prediabetic state; technology /technique development

DESCRIPTION (provided by applicant): Our ultimate goal is to develop and commercialize new, sensitive, specific, non-invasive and "user-friendly" immunodiagnostic assays based on patients' serum for the early detection of type 2 diabetes. These assays, that would not require fasting or glucose administration, would improve diagnosis, disease progression, and management. Overall, they would facilitate early population screening and prevention for this disease affecting over 6% of the US adult population, with increasing incidence in our younger population. In this SBIR Phase I project we propose to apply proprietary technologies to identify biomarkers for the early detection of type 2 diabetes. Our innovative antibody-based approach involves: i) a collection of polyclonal antibodies raised against known and unknown human proteins; and ii) a proprietary protein array allowing multiplex analysis of a large number of clinical samples using a large number of antibodies. Phase I research will focus on the comparative analysis of serum protein expression profiles between prediabetes, type 2 diabetes patients, and normal controls using a large number of antibodies from our collection. Statistical analysis of the data points generated in this study will enable us to select antibodies that discriminate pre-diabetes and type 2 diabetes with respect to normal. Selected antibodies will be further validated in Phase II, leading to the development of specific biomarkers and immunodiagnostic assays for the early detection of type 2 diabetes.

描述（由申请人提供）：我们的最终目标是开发和商业化基于患者血清的新的、敏感的、特异性的、非侵入性的和“用户友好的”免疫诊断测定，用于早期检测2型糖尿病。这些检测不需要空腹或葡萄糖给药，将改善诊断、疾病进展和管理。总的来说，它们将促进这种疾病的早期人群筛查和预防，影响超过6%的美国成年人口，在我们的年轻人口中发病率越来越高。在这个SBIR I期项目中，我们建议应用专有技术来鉴定用于早期检测2型糖尿病的生物标志物。我们创新的基于抗体的方法包括：i）针对已知和未知人类蛋白质的多克隆抗体集合;和ii）专有蛋白质阵列，允许使用大量抗体对大量临床样品进行多重分析。I期研究将集中于使用我们收集的大量抗体对前驱糖尿病、2型糖尿病患者和正常对照之间的血清蛋白表达谱进行比较分析。本研究中产生的数据点的统计分析将使我们能够选择区分糖尿病前期和2型糖尿病相对于正常的抗体。选定的抗体将在II期进一步验证，从而开发用于早期检测2型糖尿病的特异性生物标志物和免疫诊断检测。