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

SBIR II 期：肠道炎症体外诊断中的绝对蛋白质定量

• 批准号: 2242174
• 负责人: Rebecca Buckley
• 金额: $ 99.97万
• 依托单位: CHOSEN DIAGNOSTICS INC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-03-15 至 2026-02-28
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2242174&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Absolute; protein

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is to advance clinical methods that address the extensive physiological variation that is age- and race-dependent. Well-publicized over the last few decades is the lack of healthcare solutions for diseases in preemie babies, who are born to mothers with significant socioeconomic inequalities. Case in point, necrotizing enterocolitis (NEC) is a common and often fatal gastrointestinal, or gut, emergency in premature infants that disproportionately affects African American babies. The disease has not only confounded doctors and nurses for 200 years, but also these neonatal emergencies are also frightening to almost all preemie care providers due to its high mortality rate. Its healthcare in the US requires $3 billion annually due to repeated x-ray testing, surgery, longer hospital stays, and long-term complications of its survivors. An early and accurate diagnostic test for NEC would be a disruptive paradigm shift in preemie intensive care: it would enable medical intervention to be more effective, reduce risk of disease progression, decrease medical care expenses by hundreds of millions annually, and lower mortality.The proposed project will develop requisite reagents for a diagnostic test that will enable detection of infant proteins that play a role in gut health. Absolute quantitation is a prerequisite for data interpretation and validation between experiments, laboratories, and testing platforms. Research objectives are directed toward critical technical hurdles: (1) determination of optimal reference standard to quantitate host biomolecules in clinical settings and (2) understanding the usage limitations of these reference standards in the background of high variation in the human population. Native and recombinant candidates will be compared and analyzed with various methods. Anticipated results are reference standards that are age-specific for diagnostic use in the most fragile and smallest patients and that are acceptable to regulatory stakeholders.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.

这个小企业创新研究 (SBIR) 第二阶段项目的更广泛影响是推进临床方法，解决与年龄和种族相关的广泛生理变化。过去几十年来，众所周知，早产儿疾病缺乏医疗保健解决方案，这些早产儿的母亲面临着严重的社会经济不平等。举例来说，坏死性小肠结肠炎 (NEC) 是早产儿常见且往往致命的胃肠道急症，对非裔美国婴儿的影响尤为严重。这种疾病不仅让医生和护士困惑了 200 年，而且这些新生儿紧急情况也因其高死亡率而令几乎所有早产儿护理人员感到恐惧。 由于反复的 X 射线检查、手术、较长的住院时间以及幸存者的长期并发症，其在美国的医疗保健每年需要 30 亿美元。对 NEC 进行早期准确的诊断测试将是早产儿重症监护领域的颠覆性范式转变：它将使医疗干预更加有效，降低疾病进展的风险，每年减少数亿的医疗费用，并降低死亡率。拟议的项目将开发诊断测试所需的试剂，从而能够检测在肠道健康中发挥作用的婴儿蛋白质。 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。研究目标针对关键的技术障碍：(1) 确定临床环境中定量宿主生物分子的最佳参考标准；(2) 了解这些参考标准在人群高度变异的背景下的使用限制。将使用各种方法对天然和重组候选物进行比较和分析。 预期结果是参考标准，针对最脆弱和最小的患者进行诊断，并且可以为监管利益相关者所接受。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力优点和更广泛的影响审查标准进行评估，被认为值得支持。