Serum biomarker discovery in early onset type 2 diabetes

描述（由申请人提供）：我们的最终目标是开发并商业化基于患者血清的新型、敏感、特异性、非侵入性和“用户友好”的免疫诊断方法，用于2型糖尿病的早期检测。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，它们将促进早期人群筛查和预防这种影响超过6%的美国成年人口的疾病，在我们的年轻人群中的发病率正在增加。在这个SBIR一期项目中，我们建议应用专有技术来识别2型糖尿病早期检测的生物标志物。我们创新的基于抗体的方法包括：i)收集针对已知和未知人类蛋白质的多克隆抗体；ii)一种专有的蛋白质阵列，允许使用大量抗体对大量临床样品进行多重分析。I期研究将集中于比较分析前驱糖尿病、2型糖尿病患者和正常人之间的血清蛋白表达谱，使用我们收集的大量抗体。对本研究中产生的数据点进行统计分析，将使我们能够选择区分糖尿病前期和2型糖尿病与正常人的抗体。选定的抗体将在II期进一步验证，从而开发用于2型糖尿病早期检测的特异性生物标志物和免疫诊断分析。

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.