SBIR Phase I: Absolute protein quantitation in in vitro diagnostics for gut inflammation

SBIR 第一阶段：肠道炎症体外诊断中的绝对蛋白质定量

• 批准号: 2015077
• 负责人: Sunyoung Kim
• 金额: $ 22.48万
• 依托单位: CHOSEN DIAGNOSTICS INC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-15 至 2022-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2015077&HistoricalAwards=false
• 关键词: SBIR; Phase; Absolute; protein; quantitation

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is the determination of the most accurate method of measuring protein abundance in patient samples. The answers obtained will address a fatal neonatal gut disease, necrotizing enterocolitis, that disproportionately affects African-American preterm infants and lacks disease-modifying treatments. The proposed technology will serve as a clinically-deployable diagnostic for hospitals, reference labs, and drug companies, particularly high-acuity neonatal intensive care units. The proposed project will advance the development of a diagnostic for an underserved population. In addition, the development team will include underrepresented innovators. The proposed project will optimize the choice of reference standard and detection method for protein abundance. Absolute quantification is a prerequisite for data interpretation and validation between experiments, laboratories, and testing platforms. Current clinical practice exploits only a single type of mutation that gives rise to disease; rarely do they address a target protein with extensive polymorphic variation that is age- and race-dependent. The goal of this proposal is to develop reference clinically robust standards to enable use of a new candidate biomarker in hospital pathology settings. Research objectives include: (1) identification of optimal reference standard composition for two common methods to quantify biomolecules in clinical settings and (2) understanding usage limitations of these reference standards in the background of high sequence variation in the human population.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该小型企业创新研究（SBIR）第一阶段项目的更广泛影响是确定测量患者样本中蛋白质丰度的最准确方法。获得的答案将解决致命的新生儿肠道疾病，坏死性小肠结肠炎，不成比例地影响非洲裔美国早产儿，缺乏疾病改善治疗。该技术将作为医院、参考实验室和制药公司的临床可部署诊断工具，特别是高敏度新生儿重症监护室。 拟议的项目将推动为得不到充分服务的人口制定诊断方法。 此外，开发团队将包括代表性不足的创新者。本项目将优化蛋白质丰度参考标准和检测方法的选择。 绝对定量是实验、实验室和测试平台之间数据解释和验证的先决条件。 目前的临床实践仅利用引起疾病的单一类型的突变;他们很少解决具有广泛多态性变异的靶蛋白，这是年龄和种族依赖性的。该提案的目标是制定临床稳健的参考标准，以在医院病理学环境中使用新的候选生物标志物。研究目标包括：（1）为临床环境中定量生物分子的两种常用方法确定最佳参考标准组成;（2）了解这些参考标准在人群中高度序列变异背景下的使用限制。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。