iKITT Innovative Keratitis Identity Type Test

项目总结 由感染性微生物(细菌、真菌、阿米巴和病毒)或眼睛创伤引起的溃疡性角膜炎 或者，接触化学物质是一个令人严重关切的医学问题。每年，角膜炎占930,000 医生办公室和门诊部以及58,000次急诊科就诊，直接产生1.75亿美元 医疗保健支出和超过250,000小时的临床医生时间消耗。疾病表现 包括角膜溃疡、水肿和/或导致角膜变薄和穿孔的充气不足，隆起 眼压和眼内炎的进展。因此，临床结果可能是严重的， 包括部分或全部失明，需要进行穿透性角膜移植，角膜移植，眼球摘除 还有内脏剔除。目前的临床实践包括眼科检查，以确认细菌、真菌或阿米巴。 并排除病毒、化学和创伤引起的角膜炎。不幸的是，这是极其困难的，如果不是这样的话 仅仅根据眼睛检查，不可能区分细菌性角膜炎、真菌性角膜炎或阿米巴角膜炎。 因此，角膜刮片样本被收集并送到临床实验室进行基于培养的鉴定 致病微生物。同时，疾病进展的严重程度和视力损害的真实风险 迫使临床医生经验性地开出广谱疗法的鸡尾酒，直到培养结果 几天后可供使用，届时将对处方进行调整。这股海流 视觉诊断和经验性处方疗法的临床范例鼓励不必要的使用 治疗，推迟疾病的解决，增加治疗成本，最重要的是，增加 出现治疗耐药角膜炎致病菌株的风险。Lynntech，Inc.与The 密西西比大学医学中心建议开发一种创新、快速、廉价和紧凑的 测试，称为iKITT，以有效地诊断微生物角膜炎并提供病因身份和类型 在护理地点向临床医生提供信息。这些信息将使临床医生能够摆脱当前的 经验性治疗处方范例，并开出一种集中的单一疗法，具有很高的可能性 杀死致病微生物。因此，iKITT有可能通过改变 目前的临床范例，以更好地诊断和治疗微生物角膜炎。在第一阶段的SBIR工作中，我们的 具体目标是(1)组装iKITT并展示对四种常见角膜炎的选择性识别 因果关系，(2)在临床相关范围内优化iKITT对这些靶点的特异性和敏感性 (3)通过非介入性临床研究，初步论证iKITT的潜在临床应用价值。这个 这些具体目标的成功完成应该会证明这一创新新的 微生物角膜炎诊断方法，并将使更全面的技术开发和 商业化将在未来的第二阶段工作中推进。IKITT的最终商业可用性是 可能对患有微生物角膜炎的患者人群产生高度积极的临床影响。

PROJECT SUMMARY Ulcerative keratitis caused by infectious microbes (bacteria, fungi, amoebae and viruses) or due to eye trauma or chemical exposure is a medical problem of significant concern. Annually, keratitis accounts for 930,000 Doctor’s office and outpatient clinic and 58,000 emergency department visits, resulting in $175 million in direct healthcare expenditures and consumption of over 250,000 hours of clinician time. Disease manifestation includes corneal ulcer, edema and/or hypopyon leading to corneal thinning and perforation, elevated intraocular pressure and progression to endophthalmitis. Consequently, clinical outcomes could be severe, including partial or complete loss of vision, necessity for penetrating keratoplasty, corneal grafts, enucleation and evisceration. The current clinical practice involves an eye exam to confirm bacterial, fungal or amoebic keratitis and rule out viral, chemical and trauma induced keratitis. Unfortunately, it is extremely difficult, if not impossible, to distinguish between bacterial, fungal or amoebic keratitis, simply based on the eye exam. Therefore, a corneal scrape sample is collected and sent to the clinical lab for culture based identification of the causative microbe. Meanwhile, the severity of disease progression and the real risk of vision impairment force the clinician to empirically prescribe a cocktail of broad spectrum therapeutics until culture results become available several days later, at which time adjustments to the prescription are made. This current clinical paradigm of visually diagnosing and empirically prescribing therapy encourages the unnecessary use of therapeutics, delays disease resolution, increases the cost of treatment, and most importantly, increases the risk of emergence of therapeutic resistant keratitis causative strains. Lynntech, Inc. in collaboration with the University of Mississippi Medical Center proposes to develop an innovative, rapid, inexpensive and compact test, termed iKITT, to effectively diagnose microbial keratitis and provide causative identity and type information to the clinician at the point-of-care. This information will enable the clinician to shed the current empirical therapeutic prescription paradigm and prescribe a focused monotherapy that has a high likelihood of killing the causative microbe. Thus, iKITT has the potential to sustain major clinical impact by changing the current clinical paradigm to better diagnose and treat microbial keratitis. During this Phase I SBIR effort, our specific aims are to (1) assemble iKITT and demonstrate selective identification of four common keratitis causatives, (2) optimize specificity and sensitivity of iKITT to these targets in the clinically relevant range and (3) preliminarily demonstrate potential clinical utility of iKITT via a non-interventional clinical study. The successful completion of these specific aims should demonstrate ample feasibility of this innovative new microbial keratitis diagnosis approach, and will enable more comprehensive technology development and commercialization thrusts in a future follow-on Phase II effort. The eventual commercial availability of iKITT is likely to sustain high positive clinical impact for the patient populace suffering from microbial keratitis.