Large Algorithm Setting and Validation Study

In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay. The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.

NCT Number	NCT07607470
Lead Sponsor	Nanopath, Inc
Conditions	Bacterial Infections, Bacterial Infections and Mycoses, Infections, Vaginitis, Vaginal Diseases, Genital Diseases, Female, Female Urogenital Diseases, Urogenital Disease +5 more
Enrollment	1,000 participants
Start Date	2026-06-03
Primary Completion	2026-12 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-20