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）二期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。在过去的几十年里，众所周知的是缺乏针对早产儿疾病的医疗保健解决方案，这些婴儿的母亲在社会经济方面存在严重的不平等。例如，坏死性小肠结肠炎（NEC）是早产儿中一种常见且通常致命的胃肠道或肠道急症，对非裔美国婴儿的影响尤为严重。这种疾病不仅困扰了医生和护士200年，而且由于其高死亡率，这些新生儿紧急情况也使几乎所有早产儿护理提供者感到恐惧。由于反复的x光检查、手术、更长的住院时间以及幸存者的长期并发症，它在美国的医疗保健每年需要30亿美元。对NEC进行早期和准确的诊断测试将是早产儿重症监护的颠覆性范式转变：它将使医疗干预更有效，降低疾病进展的风险，每年减少数亿美元的医疗费用，并降低死亡率。拟议的项目将开发诊断测试所需的试剂，以检测在肠道健康中起作用的婴儿蛋白质。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。研究目标是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口高度变化背景下的使用局限性。将用各种方法对原生和重组候选物进行比较和分析。预期结果是针对年龄的参考标准，用于最脆弱和最小的患者的诊断，并为监管利益相关者所接受。该奖项反映了美国国家科学基金会的法定使命，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。