Disease and vaccine monitoring based on non-invasive genital tract liquid biopsy sampling.

Introduction

The ability to easily obtain appropriate and reliable biological samples is critical to advance life sciences and public/personal health. Having a sample that is non-invasive and can be self-collected at home has major acceptance and feasibility advantages.

Background

Our team demonstrated that first-void urine (FVU) samples can replace clinician-collected cervical samples to prevent cervical cancer caused by the Human Papilloma virus (HPV). Using the initial or first void urine stream is crucial here. Indeed, the outer layers of the epithelium of the genital tract exfoliate and, together with the genital mucus, form the utero-cervico-vaginal smear. This accumulates between the labia minora, around the urethral opening, and upon initiation of urination, this discharge is washed away with the FVU.

Project Goals

URISAMP uses HPV infection and vaccination models to prove the hypothesis that FVU is the ideal liquid genital tract biopsy to monitor immune response for women. The project will focus on the following objectives:

1. Identify and validate analytical methods to detect the relatively low and fluctuating concentration of potential biomarkers in FVU.
2. Provide protocols to study neutralizing antibodies and examine antigen-antibody interactions.
3. Demonstrate how FVU sampling can enhance our knowledge regarding:
   • The biology of HPV
   • Genital tract immunology
   • Mechanisms of infection and transmission
   • The biological basis of prevention
   • Potential correlates of protection

Impact

URISAMP will contribute to simplifying and facilitating sexually transmitted infection (STI) vaccine research and provide valuable data for disease modeling. Moreover, if URISAMP proves successful, and FVU can also replace other sample types (e.g., blood), applications will largely extend the STI field. Its impact as a novel diagnostic and prognostic tool for health assessment will be substantial.