I-Corps: A Multi-system Platform for Addressing Women's Health Outcomes

I-Corps项目的更广泛影响/商业潜力是开发一个软件平台，可以推进妇女健康研究和关于阴道生态失调（VD）或阴道微生物群失衡原因的知识库。在全球范围内，VD发病率最高的是北美（27%）、撒哈拉以南非洲（25%）和拉丁美洲（24%）。超过32%的艾滋病毒感染归因于性病。迄今为止，没有证据可以充分解释dvd相关疾病的原因；然而，迫切需要进一步了解这些过程，并确定早期检测阴道生态失调的生物标志物。此外，鉴于VD在全球的流行，解决VD问题和针对性预防可能会减轻VD相关疾病的负担，并降低VD和VD相关疾病的全球成本。目前，324万妇女从未咨询过妇产科专业人员，现有的阴道健康解决方案难以获得，缺乏性别包容性，也没有充分解决有特定阴道健康需求的育龄个体的问题。此外，自我诊断可能导致缺乏对病情的治疗，导致额外的医疗负担和经济费用。这个I-Corps项目的基础是开发一个软件平台，旨在让所有种族和性别的个人参与、教育和增强其能力，研究和倡导阴道健康。该多系统方法包括三个方面：1)准确、全面的阴道健康风险评估算法；2)交互式教育平台；3)家庭自采样本试剂盒。该算法利用新一代测序（全外显子组测序和16S rRNA基因测序）、基质辅助激光解吸/电离（MALDI）飞行时间质谱（TOF-MS）和核磁共振（NMR）光谱等分析方法的数据输入来评估个人患VD和VD相关疾病的风险。除了检测已知的生物标志物外，目标是利用公开的数据集、文献检索和微生物学和免疫学专业知识，鉴定出新的生物标志物，包括阴道拭子样本中差异表达的免疫基因、宿主防御代谢物和细菌蛋白。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。

The broader impact/commercial potential of this I-Corps project is the development of a software platform that may advance women's health research and the knowledge base of the causes of vaginal dysbiosis (VD), or an imbalance of the vaginal microbiome. Globally, the rates of VD are highest in North America (27%), Sub-Saharan Africa (25%), and Latin America (24%). Upwards of 32% of HIV infections are attributed to VD. To date, there is no evidence to explain fully the cause of VD-associated conditions; However, there is an urgent need to further understand these processes and identify biomarkers for early detection of vaginal dysbiosis. In addition, given the prevalence of VD globally, addressing VD issues and targeting prevention may decrease the burden of VD-associated conditions and decrease global costs of VD and VD-associated conditions. Currently, 3.24 million women have never consulted an obstetrics and gynecology (OB/GYN) professional, and existing vaginal health solutions are inaccessible, lack gender inclusivity, and do not fully address issues of child-bearing individuals with specific vaginal health needs. Also, self-diagnosis may result in lack of treatment of the condition, leading to additional medical burdens and financial costs.This I-Corps project is based on the development of a software platform that aims to engage, educate, and empower individuals of all ethnicities and genders to research and advocate for vaginal health. This multi-system approach incorporates three aspects: 1) an accurate, comprehensive vaginal health risk assessment algorithm, 2) an interactive educational platform, and 3) an at home self-sample collection kit. The proposed algorithm utilizes data inputs from analytical methods like next-generation sequencing (whole exome sequencing and 16S rRNA gene sequencing), matrix-assisted laser desorption/ionization (MALDI) time-of-flight mass spectrometry (TOF-MS), and nuclear magnetic resonance (NMR) spectroscopy to assess an individual’s risk for VD and VD-associated conditions. The goal is to identify novel biomarkers including differentially expressed immune genes, host-defense metabolites, and bacterial proteins in vaginal swab samples using publicly available datasets, literature searches, and microbiological and immunological expertise in addition to detecting known biomarkers.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.