I-Corps Program for A rapid instrument-free diagnostic assay for the early detection and quantification of sepsis biomarkers in blood.

 描述（由申请人提供）：本拟定SBIR I期研究的目的是完成用于脓毒症诊断和管理的新型血液生物标志物检测pScreen-Sep（tm）的原理验证。pScreen- Sep（tm）有几个独特的功能。它是完全一次性的（单次使用），不需要外部电子设备（即，台式或手持设备），因此易于使用且价格实惠;它也是一种定量和灵敏的平台，因此它提供了关键脓毒症生物标志物（如降钙素原（PCT））水平的准确和精确定量。目前的研究表明，PCT是一种有前途的生物标志物，可用于指示高危患者的脓毒症早期发作。严重脓毒症、全身感染和器官功能障碍或组织灌注不足每年影响超过一百万美国人，并且脓毒症的发病率以急剧的速度增加。严重脓毒症导致20-50%的患者死亡，是美国总体死亡的第十大原因，而存活的患者在其一生中通常经历疼痛、身体功能受损和总体健康状况比一般人群差。脓毒症和相关的住院费用每年超过200亿美元，仅在美国，使其成为美国医院治疗的最昂贵的疾病。与有效的脓毒症治疗相关的主要挑战之一是 早期识别和诊断。发现在观察到低血压后1小时内开始使用抗生素可显著降低脓毒症的死亡率，但超过50%的患者在低血压发生后6小时内未使用抗生素。一项研究表明，在低血压发作后的前6小时内延迟抗生素治疗，生存率每小时下降7.6%。对于脓毒症的诊断和管理，存在对诊断工具的明确且迫切的需求。我们的解决方案使医生和急救人员能够在患者的护理点快速监测和诊断潜在的脓毒症。pScreen-sep（tm）基于卡内基梅隆大学开发的专利保护技术，该技术已在我们的实验室得到广泛验证。在第一阶段的提案中，我们将优化最新原型的关键要素，并完成包括阳性和阴性对照在内的详细验证研究。支持FDA上市前批准的临床试验随后将进入第二阶段。

 DESCRIPTION (provided by applicant): The objective of this proposed SBIR Phase I is to complete the proof-of-principle of a novel blood based biomarker assay for the diagnosis and management of Sepsis, pScreen-Sep(tm). pScreen- Sep(tm) has several unique features. It is fully disposable (single use) and does not requires external electronic equipment (i.e., benchtop or handheld devices), hence it is easy to use and very affordable; it is also a quantitative and sensitive platform, hence it provides an accurate and precise quantification of the level of key sepsis biomarkers, such as procalcitonin (PCT). Current research has shown PCT to be a promising biomarker for indicating early onset of sepsis in at risk patients. Severe sepsis, systemic infection and organ dysfunction or tissue hypoperfusion, affects over a million Americans every year, and the incidence of sepsis is increasing at a drastic rate. Severe sepsis kills 20-50% of patients and is the 10th leading cause of death overall in the US, while patients who survive often experience pain, impaired physical functionality, and overall worse health than the general population during their lifetime. Sepsis and related hospitalization cost over $20 billion annually in the US alone, making it the most expensive condition treated in US hospitals. One of the major challenges associated with effective sepsis treatment is the difficulty in early recognition and diagnosis. Starting antibiotics within one hour following the observation of hypotension was found to significantly decrease mortality from sepsis, yet over 50% of patients do not receive antibiotics from more than six hours following onset of hypotension. One study showed that survival decreased by 7.6% per hour that antimicrobial therapy was delayed in the first six hours following the onset of hypotension. A clear and critical need for a prognostc tool exists for diagnosis and management of sepsis. Our solution enables physicians and first responders to rapidly monitor and diagnose potential sepsis at the Point-of-Care of patients. pScreen-sep(tm) is based on a patent-protected technology developed at Carnegie Mellon University, which has been extensively verified in our laboratory. In this Phase I proposal, we will optimize key elements of our latest prototype and complete a detailed validation study that includes positive and negative controls. A clinical trial to support the FDA premarket approval would then follow in a Phase II effort.