I-Corps: Characterization of the Vaginal Microbiome Through Sampling Kits

I-Corps项目更广泛的影响/商业潜力是使阴道微生物组检测解决方案得到更广泛的采用。最常见的阴道失调是细菌性阴道病（BV），在任何时候都有30%的女性受到影响。感染细菌性阴道炎会增加女性性传播感染、尿路感染的风险，如果怀孕，还会导致早产、低出生体重和自然流产。然而，大多数女性甚至不知道自己患有细菌性阴道炎。细菌性阴道炎只有在出现症状时才进行治疗，但所有病例中有一半是无症状的。因此，有数百万患有细菌性阴道炎的妇女，她们面临感染和不良妊娠结局的风险，但却没有意识到自己的风险。这项技术将允许离散的家庭测试，包括一个易于理解的报告，可以直接与患者的医生共享。这个I-Corps项目将探索用于分析阴道微生物组（细菌）的家庭取样试剂盒的商业潜力。我们的愿景是向妇女提供有关其健康的新知识，并推动围绕与女性有关的细菌性疾病的创新护理。我们的技术核心是双重的——DNA测序和生物信息学。对于DNA测序，我们的技术使用Illumina测序仪分析阴道细菌样本以获得部分细菌基因组。然后使用专有的生物信息学管道对样品中存在的细菌进行分类和量化。对细菌进行分类可以让用户更好地了解它们如何获得并保持健康。

The broader impact/commercial potential of this I-Corps project is to enable wider adoption of vaginal microbiome testing solutions. The most common vaginal dysbiosis is bacterial vaginosis (BV) which affects 30% of women at any given time. Having BV puts women at risk for increased incidence of sexually transmitted infections, urinary tract infections, and, if pregnant, preterm birth, low birth weight, and spontaneous abortion. Yet, most women don't even know they have BV. BV is only treated if it is symptomatic, but half of all cases are asymptomatic. Therefore, there are millions of women with BV, who are at risk for infections and adverse pregnancy outcomes, but are unaware of their risk. This technology would allow for discrete at-home testing that includes an easy to understand report that can be shared directly with the patient's physician.This I-Corps project will explore the commercial potential of an at-home sampling kits for analyzing the vaginal microbiome (bacteria). The vision is to empower women with new knowledge about their health, and drive innovative care around female related bacterial disorders. The core of our technology is twofold - DNA sequencing and bioinformatics. For DNA sequencing, our technology uses Illumina sequencers to analyze a vaginal bacterial sample to attain part of the bacterial genomes. A proprietary bioinformatics pipeline is then used to categorize and quantify the bacteria present in the sample. Classifying the bacteria then allows the user to better understand how they can get and stay healthy.