Metagenomic Community State Types for Bacterial Vaginosis Diagnosis

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Solution Overview

Problem

Current methods for diagnosing and treating bacterial vaginosis (BV) are inadequate due to reliance on species-level composition of the vaginal microbiota, which fails to account for functional differences between strains, leading to poor efficacy and high recurrence rates.

Innovation Solution

The development of metagenomic community state types (MgCSTs) that classify vaginal microbiomes based on both species composition and functional potential, using a two-step classifier to identify MgCSTs associated with BV, enabling precise prognostic, diagnostic, and therapeutic strategies.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If species-level composition methods are used to diagnose and treat bacterial vaginosis, then the diagnostic approach is simple and widely applicable, but the treatment efficacy is poor and recurrence rates are high due to inability to account for functional differences between strains

Engineering Contradiction:
Improveease of diagnosisVSAvoidtreatment efficacy
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The invention segments the vaginal microbiome classification from species-level to strain-level by introducing metagenomic subspecies (mgSs) and metagenomic community state types (MgCSTs). This segmentation allows differentiation of functionally distinct strains within the same species, enabling more precise diagnostic and therapeutic strategies that account for strain-specific functional differences while maintaining clinical applicability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention changes the classification parameter from species-level composition to strain-level metagenomic composition. By using MgCSTs that incorporate both taxonomic and functional information, the system transforms the diagnostic parameter to capture functional differences between strains, thereby improving treatment efficacy without sacrificing ease of use

Inventive Principle:
Principle #35Parameter changes

2Reliability

If strain-specific functional differences are incorporated into microbiome classification, then treatment precision and efficacy are improved, but the complexity of classification and analysis increases

Engineering Contradiction:
Improvetreatment precisionVSAvoidclassification complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention creates a universal classification framework (MgCSTs) that simultaneously captures taxonomic composition and functional potential. This multi-functional classification system integrates both species identity and strain-specific functional characteristics into a unified framework, improving treatment precision while maintaining systematic organization that reduces analytical complexity

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The invention uses metagenomic sequencing data to create digital representations (copies) of vaginal microbiome communities at the strain level. By analyzing metagenomic reads and assigning MgCSTs based on sequence data rather than requiring live bacterial cultures, the system achieves strain-level precision without the complexity of working with live cultures

Inventive Principle:
Principle #26Copying

Data Source

PatentUS20250111951A1Methods for describing vaginal microbiomes and use of the same in prognostic, diagnostic, and therapeutic strategies for bacterial vaginosis
Publication Date: 2025.04.03 UNIV OF MARYLAND
  • US20250111951A1 patent drawing
  • US20250111951A1 patent drawing
  • US20250111951A1 patent drawing

AI summary

A Lactobacillus-dominated vaginal microbiome provides the first line of defense against numerous adverse genital tract health outcomes. However, there is limited understanding of the mechanisms by which the vaginal microbiome modulates protection. Metagenomic community state types (mgCSTs), which uses metagenomic sequences to describe and define vaginal microbiomes based on both composition and function are described herein, along with their use in prognostic, diagnostic and therapeutic applications against bacterial vaginosis.