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

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.