Precision DNA PCR-based Assay for Gardnerella vaginalis species in bacterial vaginosis
Overview
This new PCR-based companion diagnostic assay leverages genetic analysis to identify specific members of the Gardnerella vaginalis species and detects resistance to metronidazole, the current first-line treatment for bacterial vaginosis (BV). BV is a prevalent vaginal infection with ~30% annual incidence, high recurrence rates and limited treatment efficacy due to the genomic variation in G. vaginalis. Notably, G. vaginalis has recently been reclassified as a genus encompassing multiple distinct species, reflecting its considerable genetic diversity. Our researchers have identified multiple distinct genospecies and revealed that 5 species exhibit 100% resistance to metronidazole. By enabling rapid, accurate identification of resistant strains, this diagnostic assay supports personalized treatment strategies, reduces recurrence rates, and guides clinicians toward the most effective therapies.
Developed by Dr. Katherine Innamorati and Dr. Garth Ehrlich at Drexel University, this innovation integrates cutting-edge genomics with practical diagnostics to support precision medicine in reproductive health. This technology is ready for rapid and automated panel testing.
Market Applications
- Clinical diagnostics for BV.
- Development of targeted diagnostic kits for OB/GYN and reproductive health.
- Pharmaceutical development and companion diagnostics for BV therapies.
- Personalized medicine and antimicrobial resistance management.
- Research in microbial genomics and infectious disease.
Key Advantages
- Enables personalized treatment selection to improve clinical outcomes.
- Rapidly identifies metronidazole-resistant G. vaginalis strains.
- Reduces recurrence and treatment failure rates.
- Supports antibiotic stewardship by minimizing unnecessary antibiotic exposure.
Problems Solved
- High failure rate of first-line metronidazole treatment for BV.
- Recurrence of BV due to ineffective or misdirected therapy.
- Lack of precision in current diagnostic and treatment approaches.
- Unnecessary antibiotic use, resistance development, and patient side effects.
- Increased risk of untreated BV complications, including STIs and adverse pregnancy outcomes.
Intellectual Property and Development Status
PCT application pending - PCT/US2025/31169
References
Scientific Publication from Genome Medicine
Drexel News article
Commercialization Opportunities
- Available for licensing and research collaboration.
- Stage: Ready for automated panel testing.
Contact Information